Stanbio Laboratory
Boerne, TX, US
STANBIO LABORATORY appears in FDA device records in Boerne, TX. FDA records list 47 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 12 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 47 510(k) clearances for Stanbio Laboratory between 1977 and 2009. The busiest year on record is 1983, with 7. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 4 |
| 1980 | 3 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 7 |
| 1984 | 2 |
| 1985 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 3 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K090093 | STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent | |
| K081719 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent | |
| K050283 | CREATININE LIQUICOLOR | JFY | Substantially Equivalent | |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | JFM | Substantially Equivalent | |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | DCK | Substantially Equivalent | |
| K032936 | DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR | JIX | Substantially Equivalent | |
| K032932 | DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR | LBS | Substantially Equivalent | |
| K032482 | STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM | GKR | Substantially Equivalent | |
| K020378 | QUPID PLUS E.R. | JHI | Substantially Equivalent | |
| K974429 | RAPET CRP | DCN | Substantially Equivalent | |
| K974370 | RAPET RF | DHR | Substantially Equivalent | |
| K972155 | CREATINE KINASE (CK) | CGS | Substantially Equivalent | |
| K962418 | UREA NITROGEN (BUN) LIQUI-UV | CDQ | Substantially Equivalent | |
| K941314 | STANBIO ALT/GPT (LUQUI-UV) TEST SET | CKA | Substantially Equivalent | |
| K941315 | STANBIO Y-GT (LIQUICOLOR) TEST SET | JQB | Substantially Equivalent | |
| K941313 | STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET | CJE | Substantially Equivalent | |
| K932049 | STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 | CIT | Substantially Equivalent | |
| K902204 | STANBIO CSF/URINE TOTAL PROTEIN TEST SET | JIR | Substantially Equivalent | |
| K893128 | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | CDL | Substantially Equivalent | |
| K883170 | STANBIO MAGNESIUM TEST SET, CAT. NO 0130 | JGJ | Substantially Equivalent | |
| K880144 | STANBIO SYPHILIS RPR TEST, NO. 1170 | GMQ | Substantially Equivalent | |
| K880467 | STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR | JIY | Substantially Equivalent | |
| K870746 | STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 | JFJ | Substantially Equivalent | |
| K851278 | ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 | LDP | Substantially Equivalent | |
| K842544 | STANBIO QUICK-TELL MONOCLONAL INDIRECT | JHJ | Substantially Equivalent | |
| K832867 | FERTITUBE PREGNANCY TEST #1120 | JHJ | Substantially Equivalent | |
| K832640 | QUICK-TELL INDIRECT PREGNANCY TEST | JHJ | Substantially Equivalent | |
| K832557 | FERTITELL DIRECT PREGNANCY TEST #1100 | JHJ | Substantially Equivalent | |
| K832444 | ENZYMATIC TRIGLYCERIDES #2000 | CDT | Substantially Equivalent | |
| K832159 | UNITIZED ENZYMATIC GLUCOSE TEST SET | CGA | Substantially Equivalent | |
| K831864 | URIC-ACID TEST ENZYMATIC COLORIMETRIC | KNK | Substantially Equivalent | |
| K831863 | CHOLESTEROL-ENZYMATIC REAGENT SET | CHH | Substantially Equivalent | |
| K831858 | TRIGLYCERIDES REAGENT SET | CDT | Substantially Equivalent | |
| K823237 | BARBITURATE TEST SET #0550-050 | DJN | Substantially Equivalent | |
| K813349 | BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL | DIF | Substantially Equivalent | |
| K810055 | STANBIO BILIRUBIN TEST SET | CIG | Substantially Equivalent | |
| K801014 | STANBIO ACETAMINOPHEN TEST SET #0850 | LDP | Substantially Equivalent | |
| K800693 | STANBIO PROSTATIC ACID PHOSPHATASE TEST | CKE | Substantially Equivalent | |
| K800190 | STANBIO DIRECT URIC ACID TEST SET #0770 | CDH | Substantially Equivalent | |
| K781865 | IRON BINDING CAPICITY MODEL 0370 | JIY | Substantially Equivalent | |
| K781635 | CHLORIDE TEST SET, CAT.# 0210 | CHJ | Substantially Equivalent | |
| K780545 | SR-PLUS DIRECT CHOLESTEROL TEST | CGO | Substantially Equivalent | |
| K780110 | CSF TOTAL PROTEIN TEST SET #0340 | JGQ | Substantially Equivalent | |
| K772257 | ALKALINE PHOSPHATASE TEST SET | CIO | Substantially Equivalent | |
| K771856 | DIR. QUANT. COLOR. DETERM. SERUM CREAT. | CGX | Substantially Equivalent | |
| K771771 | QUAN. COLOR. DETER. OF SERUM ALBUMIN | DCF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1616487 | 1616487 | STANBIO LABORATORY | 1261 NORTH MAIN ST., Boerne, TX 78006 US | 2026 | and 73 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- CDHAcid, Uric, Phosphotungstate Reduction
- JHJAgglutination Method, Human Chorionic Gonadotropin
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- GTYAntigens, All Groups, Streptococcus Spp.
- GMQAntigens, Nontreponemal, All
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- CJYAzo Dye, Calcium
- CDLBerthelot Indophenol, Urea Nitrogen
- CEKBiuret (Colorimetric), Total Protein
- JIOBlood, Occult, Colorimetric, In Urine
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- DKBCalibrators, Drug Mixture
- JFJCatalytic Methods, Amylase
- GKGCentrifuge, Hematocrit
- JGYColorimetric Method, Triglycerides
- DKJColorimetry, Salicylate
- GLKControl, Hematocrit
- GGMControl, Hemoglobin
- CICCresolphthalein Complexone, Calcium
- IFBCytocentrifuge
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- DIFDrug Mixture Control Materials
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFMEnzymatic Method, Bilirubin
- JFYEnzymatic Method, Creatinine
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- GKFInstrument, Hematocrit, Automated
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- DJNMercury Dithiazone, Colorimetry, Barbiturate
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- GKRSystem, Hemoglobin, Automated
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- GIOTube, Collection, Capillary Blood
- JGQTurbidimetric, Total Protein
- JHWU.V. Method, Cpk Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0490-2024 | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values. | Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coating solution resulting in precipitation during coating runs. The device defect can cause false negative results that may lead to a delay in treatment of patients with associated conditions such as diabetic ketoacidosis. | Class II | Open, Classified | |
| Z-0905-2022 | Separation Technology Creamatocrit Plus, Catalog Number: 100-146 | The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants) | Class II | Terminated | |
| Z-2203-2021 | Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. | Class III | Terminated | |
| Z-2202-2021 | Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. | Class III | Terminated | |
| Z-2201-2021 | Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. | Class III | Terminated | |
| Z-2200-2021 | Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. | Class III | Terminated | |
| Z-2199-2021 | Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. | Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. | Class III | Terminated | |
| Z-1070-2018 | RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis. | All patient serum samples yield a weakly positive test result. | Class II | Terminated | |
| Z-2926-2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany. | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts. | Class II | Terminated | |
| Z-0076-2007 | Stanbio Laboratory SIRRUS Direct HDL Cholesterol LiquiColor, Catalog #S0590-540; kit contains 6 x 90 tests, HDL Buffer (R1) and HDL Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | Terminated | ||
| Z-0075-2007 | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-080; test kit contains 2/30mL container of Direct HDL-Cholesterol Buffer (R1) and 2/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | Terminated | ||
| Z-0074-2007 | Stanbio Laboratory Direct HDL Cholesterol LiquiColor, Catalog #0590-040; test kit contains 1/30mL container of Direct HDL-Cholesterol Buffer (R1) and 1/10mL container of Direct HDL-Cholesterol Enzyme (R2); in vitro diagnostic distributed by Stanbio Laboratory, Boerne, TX. | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain