Cleared Traditional

AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS (K862299) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862299 · Amresco, Inc. · Chemistry device
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Jul 1986
Decision
14d
Days
Class 2
Risk

K862299 is an FDA 510(k) clearance for the AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 14 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 Amresco, Inc. devices

Submission Details

510(k) Number K862299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1986
Decision Date July 01, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 68
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K862299.
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
K872512 · Em Diagnostic Systems, Inc. · Aug 1987
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
K872513 · Em Diagnostic Systems, Inc. · Aug 1987
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
K862359 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1986
A-GENT LIQUID TOTAL BILIRUBIN
K860424 · Abbott Laboratories · Apr 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · Em Diagnostic Systems, Inc. · Mar 1986
ABBOTT TDT EIA
K843908 · Abbott Laboratories · Apr 1985