Cleared Traditional

K890540 - ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC

K890540 is an FDA 510(k) clearance for ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K890540 · Abbott Laboratories · Chemistry device
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Feb 1989
Decision
24d
Days
Class 2
Risk

K890540 is an FDA 510(k) clearance for the ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 24 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K890540

510(k) Number K890540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1989
Decision Date February 27, 1989
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGS Device Classification - Class 2, Special Controls

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 105
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K890540.
ROCHE(R) CARDIOSCREEN-CK
K891462 · Roche Diagnostic Systems, Inc. · May 1989
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
K891470 · Trace Scientific , Ltd. · May 1989
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
K890609 · Intl. Immunoassay Laboratories, Inc. · Mar 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
K884547 · Em Diagnostic Systems, Inc. · Feb 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
K884546 · Em Diagnostic Systems, Inc. · Feb 1989
VISION CREATINE KINASE
K883946 · Abbott Laboratories · Oct 1988