Cleared Traditional

K843377 - CREATININE ASSAY KIT

K843377 is the FDA 510(k) clearance for CREATININE ASSAY KIT by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K843377 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Sep 1984
Decision
31d
Days
Class 2
Risk

K843377 is an FDA 510(k) clearance for the CREATININE ASSAY KIT. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on September 28, 1984 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K843377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date September 28, 1984
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 111
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K843377.
TECHNICON CHEMI
K852565 · Technicon Instruments Corp. · Jul 1985
CREATINE LIQUID STABLE REAGENT SET
K851849 · Medical Analysis Systems, Inc. · May 1985
TDX REA CREATININE
K843916 · Abbott Laboratories · Oct 1984
CREATININE TEST
K843179 · Sclavo, Inc. · Sep 1984
SYSTEMATE CREATININE 67223
K843105 · Em Diagnostic Systems, Inc. · Aug 1984
CREATININE ASSAY KIT-KINETIC OR ENDPOINT
K842159 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984