Cleared Traditional

K891462 - ROCHE CARDIOSCREEN-CK

K891462 is the FDA 510(k) clearance for ROCHE CARDIOSCREEN-CK by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K891462 · Roche Diagnostic Systems, Inc. · Chemistry device
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May 1989
Decision
68d
Days
Class 2
Risk

K891462 is an FDA 510(k) clearance for the ROCHE(R) CARDIOSCREEN-CK. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on May 22, 1989 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K891462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1989
Decision Date May 22, 1989
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 90
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K891462.
COULTER CK (CREATINE KINASE) REAGENT
K901267 · Coulter Corp. · May 1990
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
K893007 · Helena Laboratories · Jul 1989
BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME
K893269 · Beckman Instruments, Inc. · Jul 1989
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
K891470 · Trace Scientific , Ltd. · May 1989
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · Abbott Laboratories · Feb 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
K884547 · Em Diagnostic Systems, Inc. · Feb 1989