Quantimetrix Corp.
Redondo Beach, CA, US
QUANTIMETRIX CORP. appears in FDA device records in Redondo Beach, CA. FDA records list 39 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 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 39 510(k) clearances for Quantimetrix Corp. between 1983 and 2016. The busiest year on record is 1983, with 5. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 5 |
| 1984 | 3 |
| 1985 | 4 |
| 1986 | 3 |
| 1988 | 1 |
| 1991 | 1 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 2 |
| 1999 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2006 | 3 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K152117 | Dropper hsCRP High Sensitivity CRP Control | JJX | Substantially Equivalent | |
| K142262 | AUTION CHECK PLUS | JJW | Substantially Equivalent | |
| K113177 | COMPLETE D 25-OH VITAMIN D CONTROL | JJX | Substantially Equivalent | |
| K103744 | DROPPER A1C DIABETES CONTROL | JJX | Substantially Equivalent | |
| K062942 | QUANTIMETRIX NICOSURE COTININE URINE CONTROL | LAS | Substantially Equivalent | |
| K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | JJT | Substantially Equivalent | |
| K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | DIF | Substantially Equivalent | |
| K032791 | GLYCOHEMOSURE HBA1C CONTROL | GGM | Substantially Equivalent | |
| K030826 | PRECISET DAT AMPHETAMINE | DIJ | Substantially Equivalent | |
| K021393 | PRECISET DAT PLUS | DKB | Substantially Equivalent | |
| K013662 | MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS | JHO | Substantially Equivalent | |
| K010337 | LIPOPRINT SYSTEM, LDL SUBFRACTIONS | JHO | Substantially Equivalent | |
| K010598 | SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL | JPK | Substantially Equivalent | |
| K993723 | CARDIASURE CARDIAC MARKERS CONTROL | JJT | Substantially Equivalent | |
| K973894 | IMMUSURE | JJY | Substantially Equivalent | |
| K970862 | SPINALSCOPICS | JJY | Substantially Equivalent | |
| K943394 | PROSTAT CONTROL | JJY | Substantially Equivalent | |
| K943925 | SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING | JJR | Substantially Equivalent | |
| K941130 | ASSURE URINE HCG CONTROL | JJX | Substantially Equivalent | |
| K932623 | QUANTIMETRIX BLOOD GLUCOSE CONTROLS | JIX | Substantially Equivalent | |
| K931523 | QUANTIMETRIX C-CLEAR(TM) | JMA | Substantially Equivalent | |
| K925256 | QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL | JJY | Substantially Equivalent | |
| K913346 | QUANTIMETRIX AMMONIA CONTROLS | JJX | Substantially Equivalent | |
| K880701 | QUANTIMETRIX SERUM ENZYME CONTROL | JJT | Substantially Equivalent | |
| K863388 | QUANTIMETRIX DRUG FREE SERUM CONTROL | DIF | Substantially Equivalent | |
| K861420 | QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL | JJY | Substantially Equivalent | |
| K860942 | QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID | JJY | Substantially Equivalent | |
| K853932 | QUANTTEST TOTAL PROTEIN ASSAY | CEK | Substantially Equivalent | |
| K853930 | QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT | CEK | Substantially Equivalent | |
| K853933 | QUANTIMETRIX HUMAN SERUM THERAPEUTIC DRUG CONTROL | DIF | Substantially Equivalent | |
| K853931 | QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL | JJY | Substantially Equivalent | |
| K843818 | HUMAN SERUM ANTICONVULSANT DRUG CONTROL | DIF | Substantially Equivalent | |
| K843679 | HUMAN SERUM CARDIOACTIVE DRUG CONTROL | DIF | Substantially Equivalent | |
| K834505 | HUMAN SERUM ELECTROLYTE CONTROL-LIQUID | JJR | Substantially Equivalent | |
| K832045 | ACETAMINOPHER ASSAY KIT | LDP | Substantially Equivalent | |
| K831526 | URINE TOTAL PROTEIN CONTROL | JJW | Substantially Equivalent | |
| K831527 | SPINAL FLUID TOTAL PROTEIN CONTROL | JJX | Substantially Equivalent | |
| K831336 | SALICYLATE ASSAY KIT | DKJ | Substantially Equivalent | |
| K830934 | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN | CJW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020715 | 2020715 | QUANTIMETRIX CORP. | 2005 Manhattan Beach Blvd, REDONDO BEACH, CA 90278 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- CEKBiuret (Colorimetric), Total Protein
- CJWBromcresol Purple Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- DKBCalibrators, Drug Mixture
- LDPColorimetry, Acetaminophen
- DKJColorimetry, Salicylate
- GGMControl, Hemoglobin
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- JJRElectrolyte Controls (Assayed And Unassayed)
- JHOElectrophoretic Separation, Lipoproteins
- JJTEnzyme Controls (Assayed And Unassayed)
- DIJLead, Delta Amino Levulinic Acid
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2257-2018 | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods. | The kits contained an incorrect lot of Dropper Plus Level 1 vials | Class III | Terminated | |
| Z-0516-2009 | Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation. | This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group. | Terminated | ||
| Z-0515-2009 | Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient cerebrospinal fluid samples performed manually using a hemocytometer. | This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group. | Terminated | ||
| Z-0514-2009 | Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. | This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group. | Terminated | ||
| Z-0513-2009 | Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations. | This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain