Cleared Traditional

K771840 - TOTAL BILIRUBIN

K771840 is the FDA 510(k) clearance for TOTAL BILIRUBIN by Gamma Enterprises, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K771840 · Gamma Enterprises, Inc. · Chemistry device
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Oct 1977
Decision
28d
Days
Class 2
Risk

K771840 is an FDA 510(k) clearance for the TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Gamma Enterprises, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1977 after a review of 28 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 Gamma Enterprises, Inc. devices

Submission Details

510(k) Number K771840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1977
Decision Date October 19, 1977
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 177
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K771840.
BILIRUBIN, DINGLE VALVE DPD
K781921 · Boehringer Mannheim Corp. · Jan 1979
BILIRUBIN DETERMINTAITON IN SERUM
K781610 · Fisher Scientific Co., LLC · Oct 1978
ULTRACHEM T-BILI 64971 GILFORD 3500
K780524 · Harleco · May 1978
MULTISTAT III, TOTAL BILIRUBIN TEST
K771621 · Instrumentation Laboratory CO · Sep 1977
UNIPAK TOTAL BILIRUBIN
K771089 · Harleco · Jul 1977
UNIPAK TOTAL & DIRECT BILIRUBIN
K771092 · Harleco · Jul 1977