Cleared Traditional

K983070 - CK

K983070 is an FDA 510(k) clearance for CK, 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 167-day FDA review.

K983070 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
167d
Days
Class 2
Risk

K983070 is an FDA 510(k) clearance for the CK. 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 16, 1999 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K983070

510(k) Number K983070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1998
Decision Date February 16, 1999
Days to Decision 167 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 88d · This submission: 167d
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 K983070.
CREATINE KINASE LIQUID REAGENT, MODEL C519-440
K072548 · Teco Diagnostics · Apr 2008
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
K043202 · Olympus America, Inc. · Dec 2004
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA
K021332 · Wiener Laboratories Saic · Jul 2002
CREATINE KINASE (CK)
K981218 · Abbott Laboratories · May 1998
N-ASSAY CPK-L
K980900 · Crestat Diagnostics, Inc. · Mar 1998
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
K973999 · Diagnostic Chemicals , Ltd. · Mar 1998