Chromatographic Separation, Cpk Isoenzymes
Chromatographic Separation for CPK Isoenzymes is a clinical chemistry test system that uses chromatographic methods to separate and quantify CK-MB, CK-MM, and CK-BB isoenzyme fractions, supporting the diagnosis of myocardial infarction and other conditions causing muscle damage. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JHT, regulated under 21 CFR 862.1215, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JHT
- Device Class
- FDA class 2
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 21 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | Sep 30, 2002 | Substantially Equivalent | Spectral Diagnostics, Inc. |
| K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | May 28, 1999 | Substantially Equivalent | Princeton BioMeditech Corp. |
| K930359 | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 | Apr 12, 1993 | Substantially Equivalent | Helena Laboratories |
| K904866 | COULTER CK-MB ISOENZYME REAGENT | Dec 13, 1990 | Substantially Equivalent | Coulter Electronics, Inc. |
| K904721 | DSL CK-MB (DSL #3200) | Dec 13, 1990 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | May 15, 1990 | Substantially Equivalent | Intl. Immunoassay Laboratories, Inc. |
| K896170 | REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 | Feb 16, 1990 | Substantially Equivalent | Helena Laboratories |
| K881168 | CREATINE KINASE (CK) ISOENZYME MB | Nov 10, 1988 | Substantially Equivalent | Data Medical Associates, Inc. |
| K874284 | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM | Jan 21, 1988 | Substantially Equivalent | Diagnostic Chemicals, Ltd. (Usa) |
| K872041 | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM | Sep 16, 1987 | Substantially Equivalent | Coulter Electronics, Inc. |
| K872598 | MICROMI-CK(TM) | Aug 03, 1987 | Substantially Equivalent | Intl. Immunoassay Laboratories, Inc. |
| K872592 | IMACK-MB(TM) | Jul 31, 1987 | Substantially Equivalent | Intl. Immunoassay Laboratories, Inc. |
| K831391 | SHOT GUN KIT FOR CK-MB | Nov 04, 1983 | Substantially Equivalent | Serapine Corp. |
| K823550 | CK-ISOZYME U.V. REAGENT SET | Jan 07, 1983 | Substantially Equivalent | Gelman Sciences, Inc. |
| K822124 | TITAN GEL CPK ISOENZYME SYSTEM | Nov 01, 1982 | Substantially Equivalent | Helena Laboratories |
| K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION | Jul 22, 1982 | Substantially Equivalent | Intl. Immunoassay Laboratories, Inc. |
| K810534 | GEMENI QUICK-MB SEPARATION KIT | Mar 11, 1981 | Substantially Equivalent | Gemini, Inc. |
| K791826 | CPK CLINI GEL KIT | Oct 01, 1979 | Substantially Equivalent | Clinical Sciences, Inc. |
| K790357 | CPK-CS | Apr 04, 1979 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
| K771497 | CK-MB | Aug 22, 1977 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K760028 | CPK - ISOENZYMES | Sep 15, 1976 | Substantially Equivalent | Harleco |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.