Cleared Traditional

K972743 - SIGMA DIAGNOSTICS CREATININE REAGENT

K972743 is the FDA 510(k) clearance for SIGMA DIAGNOSTICS CREATININE REAGENT by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K972743 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
61d
Days
Class 2
Risk

K972743 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 22, 1997 after a review of 61 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K972743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1997
Decision Date September 22, 1997
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
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 110
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K972743.
CREA
K981799 · Abbott Laboratories · Jul 1998
CREATININE (CREA)
K981240 · Abbott Laboratories · May 1998
RANDOX CREATININE
K973993 · Randox Laboratories, Ltd. · Mar 1998
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534 · Sigma Diagnostics, Inc. · Sep 1996
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
K951595 · Roche Diagnostic Systems, Inc. · Sep 1995
CREATININE-PO REAGENT KIT
K943924 · Synermed, Inc. · Sep 1994