Cleared Traditional

K873365 - CREATININE REAGENT

K873365 is the FDA 510(k) clearance for 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 42-day FDA review.

K873365 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
42d
Days
Class 2
Risk

K873365 is an FDA 510(k) clearance for the 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 October 2, 1987 after a review of 42 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 K873365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date October 02, 1987
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K873365.
CREATININE
K880629 · Tech-Co, Inc. · Mar 1988
PARAMAX CREATININE REAGENT
K873531 · Baxter Healthcare Corp · Nov 1987
EASY-TEST CREATININE (CREA) ITEM NO. 19009
K874088 · Em Diagnostic Systems, Inc. · Nov 1987
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · Abbott Laboratories · Sep 1987
CURAD MEDICATED PLASTIC STRIPS
K872310 · The Kendal Co. · Aug 1987
CREATININE REAGENT - PICRIC ACID METHOD
K870366 · Trace Scientific , Ltd. · Aug 1987