Cleared Traditional

K831844 - DIRECT BILIRUBIN REAGENT

K831844 is an FDA 510(k) clearance for DIRECT BILIRUBIN REAGENT, manufactured by Gilford Diagnostics. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K831844 · Gilford Diagnostics · Chemistry device
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Jul 1983
Decision
40d
Days
Class 2
Risk

K831844 is an FDA 510(k) clearance for the DIRECT BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 40 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 Gilford Diagnostics devices

FDA 510(k) Submission Details - K831844

510(k) Number K831844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1983
Decision Date July 18, 1983
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

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 215
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K831844.
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK
K832357 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
SIGMA PROCEDURE #550 DETERM. BILIRUB
K832236 · Sigma Chemical Co. · Aug 1983
GILCHEM TOTAL BILIRUBIN REAGENT
K831843 · Gilford Diagnostics · Jul 1983
TOTAL BILIRUBIN REAGENT
K830714 · Hi Chem, Inc. · Apr 1983
ULTRACHEM T-BILI
K821873 · Harleco Diagnostics · Jul 1982
TOTAL BILIRUBIN REAGENT SET
K821197 · Omega Medical Electronics · Jul 1982