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.
Cleared Devices (97)
| 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 |
| K965168 | STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) | Specialized Assays, Inc. | Feb 4, 1997 | SESE |
| K965166 | STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) | Specialized Assays, Inc. | Feb 4, 1997 | SESE |
| K961828 | LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) | Bio-Rad | Jun 11, 1996 | SESE |
| K960275 | OPUS CK-MB & TOTAL CK CONTROLS | Behring Diagnostics, Inc. | Apr 25, 1996 | SESE |
| K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | Ciba Corning Diagnostics Corp. | Apr 23, 1996 | SESE |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | Isolab, Inc. | Sep 21, 1995 | SESE |
| K951293 | QUANTITATE ENZYME VERIFIER SET | Beckman Instruments, Inc. | Apr 20, 1995 | SESE |
| K950801 | CARDIO REP LD CONTROL - CAT NO. 3325 | Helena Laboratories | Mar 30, 1995 | SESE |
| K946146 | CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION | Clinical Controls, Inc. | Jan 24, 1995 | SESE |
| K946145 | CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL | Clinical Controls, Inc. | Jan 24, 1995 | SESE |
| K944923 | CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, | Clinical Controls, Inc. | Nov 4, 1994 | SESE |
| K944247 | CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL | Cala Diagnostics | Oct 31, 1994 | SESE |
| K944246 | CARDIOCHEX CKMB MASS MEASUREMENT CONTROL | Cala Diagnostics | Oct 31, 1994 | SESE |
| K944243 | CARDIOCHEX | Cala Diagnostics | Oct 27, 1994 | SESE |
| K943684 | HICHEM ENZYME VERIFIER KIT | Hi Chem, Inc. | Oct 4, 1994 | SESE |
| K932442 | CARDIO REP RECOMBINANT CK ABNORMAL CONTROL | Helena Laboratories | Oct 28, 1993 | SESE |
| K930889 | ROCHE CARDIOTROL-CK | Roche Diagnostic Systems, Inc. | Jul 6, 1993 | SESE |
| K930875 | CKMB CONTROL - LEVEL 1,2,3 | Cala Diagnostics | Apr 13, 1993 | SESE |
| K930873 | CKMB ISOENZYME CONTROL-LEVEL 1,2.3 | Cala Diagnostics | Apr 13, 1993 | SESE |
| K925151 | LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 | Bio-Rad | Dec 17, 1992 | SESE |
| K905623 | CK-MB IMMUNOASSAY CONTROL | Seradyn, Inc. | Feb 22, 1991 | SESE |
| K903430 | LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 | Bio-Rad | Aug 23, 1990 | SESE |
| K902321 | HI CHEM ENZYME LINEARITY STANDARDS (PROD. 88235) | Hichem Diagnostics | Jun 28, 1990 | SESE |
| K896465 | CLP CK/LD ISOENZYME/IMMUNO CONTROL | Creative Laboratory Products, Inc. | Mar 1, 1990 | SESE |
| K894554 | CLP CK/LD ISOENZYME CONTROL | Creative Laboratory Products, Inc. | Oct 16, 1989 | SESE |
| K894207 | CK-MB/LD-1 CONTROL SYSTEM | Boehringer Mannheim Corp. | Aug 28, 1989 | SESE |
| K883395 | ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY | Quantimetrix Medical Industries | Sep 19, 1988 | SESE |
| K882795 | DADE(R) CK-MB IMMUNOASSAY CONTROL | Baxter Healthcare Corp | Aug 29, 1988 | SESE |
| K880701 | QUANTIMETRIX SERUM ENZYME CONTROL | Quantimetrix Corp. | Mar 24, 1988 | SESE |
| K880266 | MULTI-ENZYME LINEARITY SOLUTION | Verichem Laboratories, Inc. | Feb 18, 1988 | SESE |
| K874302 | QUANTIMETRIX TOTAL CREATINE KINASE CONTROL | Quantimetrix Medical Industries | Feb 2, 1988 | SESE |
| K874141 | TITAN GEL REP CPK/LDH ISOENZYME CONTROL | Helena Laboratories | Nov 4, 1987 | SESE |
| K872646 | VIRON(TM) | bioMerieux, Inc. | Sep 14, 1987 | SESE |
| K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL | U. S. Diagnostics, Inc. | Apr 13, 1987 | SESE |
| K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL | U. S. Diagnostics, Inc. | Apr 13, 1987 | SESE |
| K861506 | DOCUMENT ENZYME LINEARITY TEST SETS | Casco Standards | Jun 13, 1986 | SESE |
| K861512 | EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 | Em Diagnostic Systems, Inc. | May 23, 1986 | SESE |
| K861329 | ISOTRAK AMYLASE ISOENZYME CONTROL SET | Behring Diagnostics, Inc. | Apr 30, 1986 | SESE |
| K860764 | EMDS ENZYME VERIFIER, LEVELS I & II | Em Diagnostic Systems, Inc. | Apr 7, 1986 | SESE |
| K855006 | CANTROL CK/MB CONTROL | Canyon Diagnostics, Inc. | Jan 17, 1986 | SESE |
| K854973 | V-TREND OC CPK | V-Tech, Inc. | Jan 13, 1986 | SESE |
| K853373 | DELTA TROL I & II | Electro-Nucleonics Laboratories, Inc. | Aug 23, 1985 | SESE |
| K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) | Seragen Diagnostics, Inc. | Jun 25, 1985 | SESE |
| K850907 | CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ | Cala Diagnostics | Jun 25, 1985 | SESE |
| K850213 | ISOCONTROL SERUM CK-MB | Sclavo, Inc. | Mar 5, 1985 | SESE |
| K850211 | ISOCONTROL SERUM LD- | Sclavo, Inc. | Feb 7, 1985 | SESE |
| K843266 | ID ZONE NORMAL LD ISOENZYME CONTROL | Beckman Instruments, Inc. | Sep 13, 1984 | SESE |
| K843265 | ID ZINE LD ISOENZYME CONTROL ABNORM | Beckman Instruments, Inc. | Sep 13, 1984 | SESE |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | Seragen Diagnostics, Inc. | Apr 13, 1984 | SESE |
| K822984 | ID-ZONE LD ISOENZYME CONTROL | Beckman Instruments, Inc. | Nov 10, 1982 | SESE |
| K822646 | QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM | Beckman Instruments, Inc. | Sep 30, 1982 | SESE |
| K821981 | TITAN GEL CPK/LDH ISOENZYME CONTROL | Helena Laboratories | Jul 22, 1982 | SESE |
| K821183 | TARGET ISOCHECK CONTROL SERUM | Smithkline Diagnostics, Inc. | May 14, 1982 | SESE |
| K820360 | AALTO LDH ISOENZYME CONTROL SERUM | Aalto Scientific, Ltd. | Mar 4, 1982 | SESE |
| K812671 | EMBRITROL CK-MB CONTROLS | Intl. Immunoassay Laboratories, Inc. | Oct 2, 1981 | SESE |
| K810870 | GEMENI CK-MB ISOENZYME ABNORMAL SERUM | Gemini, Inc. | Apr 14, 1981 | SESE |
| K810725 | QUALITROL #65057 | Harleco | Mar 31, 1981 | SESE |
| K803305 | DUPONT 'ACA' CREATINE KINASE VERIFIERS | E.I. Dupont DE Nemours & Co., Inc. | Jan 16, 1981 | SESE |
| K800604 | CK ISOENZYME ELECTROPHORESIS CONTROL-I.D | Beckman Instruments, Inc. | Apr 10, 1980 | SESE |
| K791723 | QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) | Organon, Inc. | Oct 1, 1979 | SESE |
| K791300 | LDH ISOENZYME CONTROL | Electrophoresis Corp. of America | Aug 16, 1979 | SESE |
| K791299 | CPK ISOENZYME CONTROL | Electrophoresis Corp. of America | Aug 16, 1979 | SESE |
| K790985 | P.A.P. RIA CONTROL SERUM PACK | Mallinckrodt Critical Care | Jul 17, 1979 | SESE |
| K781100 | DELTA TEST AMYLASE/LIPASE CONTS. I,II | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 14, 1978 | SESE |
| K780801 | ISOZYME - ID CPK MARKER | Dade, Baxter Travenol Diagnostics, Inc. | Jun 13, 1978 | SESE |
| K780554 | CLIN. CHEM. CONTROL SERUM-QUANTITATE | Beckman Instruments, Inc. | Jun 6, 1978 | SESE |
| K780204 | CHEMISTRY CONTROL & REFERENCE SERUMS | Hyland Therapeutic Div., Travenol Laboratories | Mar 3, 1978 | SESE |
| K780147 | ISOENZYME SERUM CONTROL | Corning Medical & Scientific | Feb 23, 1978 | SESE |
| K771800 | ACA GLUTAMYL TRANSFERASE | E.I. Dupont DE Nemours & Co., Inc. | Oct 25, 1977 | SESE |
| K771740 | CARDIOZYME CK-CONTROL LEVEL 1 | Dade, Baxter Travenol Diagnostics, Inc. | Oct 19, 1977 | SESE |
| K771439 | PATHONORM H & L | Nyegaard & Co. A/S | Sep 2, 1977 | SESE |
| K771438 | AUTONORM | Nyegaard & Co. A/S | Sep 2, 1977 | SESE |
| K771436 | SERONORM | Nyegaard & Co. A/S | Sep 2, 1977 | SESE |
| K770973 | CARDIOZYME CK CONTROL NORMAL | Dade, Baxter Travenol Diagnostics, Inc. | Aug 4, 1977 | SESE |
| K770971 | CARDIOZYME CK-CONTROL ABNORMAL | Dade, Baxter Travenol Diagnostics, Inc. | Aug 4, 1977 | SESE |
| K770555 | CPK ISOENZYME CONTROL | Bio-Reagents & Diagnostics, Inc. | Jun 3, 1977 | SESE |
| K770049 | LDH ISOTROL T | Sigma Chemical Co. | Jan 26, 1977 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 7 clearances
- Cala Diagnostics — 6 clearances
- Bio-Rad — 6 clearances
- Helena Laboratories — 4 clearances
- Dade, Baxter Travenol Diagnostics, Inc. — 4 clearances
