JJT · Enzyme Controls (Assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660 · Class 1
Overview
| Product Code | JJT |
|---|---|
| Device Name | Enzyme Controls (Assayed And Unassayed) |
| Regulation | 21 CFR 862.1660 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.
Classification Rationale
Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 97)
Showing 20 most recent of 97 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090940 | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED | Astoria-Pacific, Inc. | Dec 14, 2009 | SESE |
| K062751 | MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER | Quantimetrix Corp. | Oct 3, 2006 | SESE |
| K030768 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL | Cliniqa Corporation | Mar 21, 2003 | SESE |
| K030102 | ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 | Bayer Healthcare, LLC | Jan 24, 2003 | SESE |
| K021498 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL | Bio-Rad | May 24, 2002 | SESE |
| K012656 | LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 | Bio-Rad | Sep 6, 2001 | SESE |
| K993723 | CARDIASURE CARDIAC MARKERS CONTROL | Quantimetrix Corp. | Nov 23, 1999 | SESE |
| K993715 | QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 | Seracare Technology | Nov 16, 1999 | SESE |
| K992430 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | Aug 30, 1999 | SESE |
| K984437 | QUANTEX ASO-CRP-RP CONTROL II | Instrumentation Laboratory CO | Feb 2, 1999 | SESE |
| K984277 | CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 | Medical Analysis Systems, Inc. | Dec 9, 1998 | SESE |
| K982845 | CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 | More Diagnostics | Aug 21, 1998 | SESE |
| K980556 | LIQUICHEK CARDIAC MARKERS CONTROL LT | Bio-Rad | Feb 25, 1998 | SESE |
| K974461 | TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL | Biosite Incorporated | Dec 10, 1997 | SESE |
| K973974 | DADE TRU-LIQUID CARDIAC CONTROL | Dade Intl., Inc. | Nov 6, 1997 | SESE |
| K972976 | CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL | More Diagnostics | Aug 29, 1997 | SESE |
| K972408 | CARDIAC STATUS CONTROLS | Spectral Diagnostics, Inc. | Jul 25, 1997 | SESE |
| K971777 | QUANTEX ASO-CRP-RF CONTROL | Instrumentation Laboratory CO | May 27, 1997 | SESE |
| K970856 | CARDIOISOZYME, CK/LD ISOENZYME CONTROL | Medical Analysis Systems, Inc. | Apr 8, 1997 | SESE |
| K965169 | STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) | Specialized Assays, Inc. | Feb 6, 1997 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 7 clearances
- Bio-Rad — 6 clearances
- Cala Diagnostics — 6 clearances
- Dade, Baxter Travenol Diagnostics, Inc. — 4 clearances
- Helena Laboratories — 4 clearances
