Cleared Traditional

K872197 - PROCEDURE NO. 552/553 BILIRUBIN

K872197 is the FDA 510(k) clearance for PROCEDURE NO. 552/553 BILIRUBIN by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K872197 · Sigma Diagnostics, Inc. · Chemistry device
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Aug 1987
Decision
66d
Days
Class 2
Risk

K872197 is an FDA 510(k) clearance for the PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 13, 1987 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 K872197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1987
Decision Date August 13, 1987
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 168
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K872197.
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
K872513 · Em Diagnostic Systems, Inc. · Aug 1987
TOTAL BILIRUBIN REAGENT - DMSO METHOD
K870364 · Trace Scientific , Ltd. · Aug 1987
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD
K870365 · Trace Scientific , Ltd. · Aug 1987
BILIRUBIN TESTER
K870095 · Wako Chemicals USA, Inc. · Jun 1987
REAGENTS 1263,1273,1284,1425,014301,053583
K871531 · American Research Products Co. · May 1987
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
K871530 · American Research Products Co. · May 1987