Cleared Traditional

K812841 - TOTAL & DIRECT BILIRUBIN REAGENT SET

K812841 is an FDA 510(k) clearance for TOTAL & DIRECT BILIRUBIN REAGENT SET, manufactured by Anco Medical Reagents & Assoc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K812841 · Anco Medical Reagents & Assoc. · Chemistry device
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Nov 1981
Decision
49d
Days
Class 2
Risk

K812841 is an FDA 510(k) clearance for the TOTAL & DIRECT BILIRUBIN REAGENT SET. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 after a review of 49 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 Anco Medical Reagents & Assoc. devices

FDA 510(k) Submission Details - K812841

510(k) Number K812841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1981
Decision Date November 27, 1981
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 218
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K812841.
ULTRACHEM T-BILI, #64971
K821462 · Emd Chemicals, Inc. · Jun 1982
BILIRUBIN(TOTAL) DETERMINATION CTMS
K820675 · The Dow Chemical Co. · Apr 1982
DOW BILIRUBIN(DIRECT) DETERMINATION
K820714 · The Dow Chemical Co. · Apr 1982
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
K812784 · Beckman Instruments, Inc. · Oct 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · Beckman Instruments, Inc. · Oct 1981
KING DIAGNOSTICS TOTAL BILIRUBIN TEST
K811881 · King Diagnostics, Inc. · Jul 1981