Cleared Traditional

K771092 - UNIPAK TOTAL & DIRECT BILIRUBIN

K771092 is the FDA 510(k) clearance for UNIPAK TOTAL & DIRECT BILIRUBIN by Harleco. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K771092 · Harleco · Chemistry device
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Jul 1977
Decision
35d
Days
Class 2
Risk

K771092 is an FDA 510(k) clearance for the UNIPAK TOTAL & DIRECT BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977 after a review of 35 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 Harleco devices

Submission Details

510(k) Number K771092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1977
Decision Date July 21, 1977
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 171
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K771092.
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
MANUEL BILIRUBIN REAGENT SET
K770121 · Harleco · Jan 1977
AUTO TOTAL BILIRUBIN REAGENT
K761218 · Harleco · Dec 1976
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN
K761027 · Harleco · Nov 1976