Lin-Zhi International Inc
Santa Clara, CA, US
LIN-ZHI INTERNATIONAL, INC. appears in FDA device records in Santa Clara, CA. FDA records list 50 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 50 510(k) clearances for Lin-Zhi International Inc between 2002 and 2026. The busiest year on record is 2002, with 9. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 9 |
| 2003 | 6 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 5 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 3 |
| 2014 | 4 |
| 2015 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 3 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | DJG | Substantially Equivalent | |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | DJG | Substantially Equivalent | |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | DJG | Substantially Equivalent | |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | DJG | Substantially Equivalent | |
| K201223 | LZI Tramadol Enzyme Immunoassay | DJG | Substantially Equivalent | |
| K192299 | LZI Cotinine II Enzyme Immunoassay | MKU | Substantially Equivalent | |
| K192433 | LZI Methadone II Enzyme Immunoassay | DJR | Substantially Equivalent | |
| K181159 | LZI Fentanyl Enzyme Immunoassay | DJG | Substantially Equivalent | |
| DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | QBK | Unknown | |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators | DJR | Substantially Equivalent | |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls | LDJ | Substantially Equivalent | |
| K141205 | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 | DJG | Substantially Equivalent | |
| K141055 | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) | DJG | Substantially Equivalent | |
| K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | LAF | Substantially Equivalent | |
| K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | DKB | Substantially Equivalent | |
| K131653 | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | DKZ | Substantially Equivalent | |
| K120763 | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS | DJG | Substantially Equivalent | |
| K120761 | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS | DJG | Substantially Equivalent | |
| K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | LAF | Substantially Equivalent | |
| K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS | DIO | Substantially Equivalent | |
| K110298 | OPIATE ENZYME IMMUNOASSAY | DJG | Substantially Equivalent | |
| K110239 | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL | LDJ | Substantially Equivalent | |
| K102210 | LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS | DKZ | Substantially Equivalent | |
| K101195 | 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | |
| K090844 | BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | |
| K081008 | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS | DJG | Substantially Equivalent | |
| K063024 | LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS | DKZ | Substantially Equivalent | |
| K062242 | METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS | LAF | Substantially Equivalent | |
| K050988 | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | DLG | Substantially Equivalent | |
| K051058 | METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | DJR | Substantially Equivalent | |
| K050945 | ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS | DIO | Substantially Equivalent | |
| K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DKB | Substantially Equivalent | |
| K050733 | OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS | DJG | Substantially Equivalent | |
| K033885 | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) | DIS | Substantially Equivalent | |
| K033866 | CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS) | DIO | Substantially Equivalent | |
| K033094 | ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) | DKZ | Substantially Equivalent | |
| K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) | DIS | Substantially Equivalent | |
| K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) | DJR | Substantially Equivalent | |
| K032461 | ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 | DIC | Substantially Equivalent | |
| K032365 | BENZODIAZEPINE ENZYME IMMUNOASSAY | JXM | Substantially Equivalent | |
| K023795 | PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) | JXN | Substantially Equivalent | |
| K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | Substantially Equivalent | |
| K023317 | METHADONE ENZYME IMMUNOASSAY | DJR | Substantially Equivalent | |
| K021887 | CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071 | LDJ | Substantially Equivalent | |
| K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | Substantially Equivalent | |
| K020395 | AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT) | DKZ | Substantially Equivalent | |
| K020368 | OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT); CATALOG # 0021 (5000 TESTS KIT) | DJG | Substantially Equivalent | |
| K020763 | COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT) | DIO | Substantially Equivalent | |
| K020254 | PHENCYCLIDINE ENZYME IMMUNOASSAY, CATALOG NUMBERS 0010 & 0011 | LCM | Substantially Equivalent | |
| K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | DLJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003610499 | 3003610499 | LIN-ZHI INTERNATIONAL, INC. | 2945 Oakmead Village Ct, Santa Clara, CA 95051 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DKCAlcohol Control Materials
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- DNNCalibrators, Ethyl Alcohol
- DLGCoating, Liquid, Glc
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- QBKMeprobamate Test System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1256-2019 | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot. | Shelf life of the product may be reduced due to degradation of the assay. | Class III | Terminated | |
| Z-1270-2014 | Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL). | Class III | Terminated | |
| Z-1179-2014 | Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers. | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products. | Class II | Terminated | |
| Z-1178-2014 | Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers. | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products. | Class II | Terminated | |
| Z-0386-2014 | Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Contents: Contains 13 mg/Ml of Norbuprenorphine in human urine with sodium azide as a preservative. Manufacturer: Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 The Norbuprenorphine Drug of Abuse (DUB) Positive control is used as assayed quality control material to monitor the precision of the Lin-Zhi International, Inc. Buprenorphine Enzyme immunoassay on the Synchron clinical analyzer. It in intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine. | Product catalog # A68825 Norbuprenorphine 13 ng/mL Level 2 Controls gives a decreased concentration reading due to the degradation of the NBUP analyte in solution. | Class III | Terminated | |
| Z-0847-2012 | Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for in-vitro diagnostic use only. Contains 300 ng/mL benzoylecgonine, 750 ng/mL d-methamphetamine, 4000 ng/m: morphine, 50 phencyclidine, 500 ng/m: oxazepam, 500 ng/mL secobarbital, 700ng/mL propoxyphene and 600 ng.mL methadone in urine buffer with dosium azide as preservitive. Drug abuse testing Lin-Zhi International, Inc.' 670 Almanor Ave. Sunnyvale, CA 94085. | Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators. | Terminated | ||
| Z-0846-2012 | Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500 tests); Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. and Barbiturate Enzyme Immunoassay R2; Enzyme Conjugate Reagent (5000 tests and 500 test packaging); Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. For in-vitro diagnostic use only. Lin-Zhi International Inc. 670 Almanor Ave., Sunnyvale, CA 94085 Product Usage: Drug testing | Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned. | Terminated | ||
| Z-0868-2012 | Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection. | Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings. | Terminated | ||
| Z-0838-2012 | Multi-Analyte Urine DAU Control (15 mL); Level 2, For in-vitro diagnostic use only. Lin-Zhi International, Inc. 670 Almanor Ave. Sunnyvale, CA 94085 Multi-Analyte Urine Drug of Drug Abuse (DAU) Controls are for use as controls in the quantitative and semi-quantitative calibration of Amphetamines Enzyme, Opiate Enzyme, Phencyclidine Enzyme, Cocaine Metabolite Enzyme, Benzodiazepine Enzyme, Barbiturate Enzyme, Methadone Enzyme and Propoxyphene Enzyme on a number of automated clinical analyzers. | Customer complaint investigation found that the Multi-Analyte Urine DAU Level 2 control was incorrectly labeled and actually contained Multi-Analyte DAU Low Level Calibrators. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain