Cleared Traditional

K893269 - BECKMAN PARAGON(TM) CREATINE KINASE ISO...

K893269 is an FDA 510(k) clearance for BECKMAN PARAGON(TM) CREATINE KINASE ISO..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K893269 · Beckman Instruments, Inc. · Chemistry device
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Jul 1989
Decision
79d
Days
Class 2
Risk

K893269 is an FDA 510(k) clearance for the BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 79 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K893269

510(k) Number K893269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date July 20, 1989
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 103
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K893269.
COULTER CK (CREATINE KINASE) REAGENT
K901267 · Coulter Corp. · May 1990
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
K894715 · Catachem, Inc. · Nov 1989
REP(TM) CK-2 STAT KIT, CAT. NO. 3074
K893007 · Helena Laboratories · Jul 1989
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
ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC
K890540 · Abbott Laboratories · Feb 1989