Cleared Traditional

K991866 - BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04

K991866 is an FDA 510(k) clearance for BILIRUBIN, manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K991866 · A.P. Total Care, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
62d
Days
Class 2
Risk

K991866 is an FDA 510(k) clearance for the BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on August 2, 1999 after a review of 62 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K991866

510(k) Number K991866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date August 02, 1999
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 213
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K991866.
DIRECT BILIRUBIN
K003693 · Jas Diagnostics, Inc. · Jan 2001
BAYER ADVIA IMS SYSTEM
K993867 · Bayer Corp. · Apr 2000
CARESIDE DIRECT BILIRUBIN
K993771 · Careside, Inc. · Dec 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · Abbott Laboratories · May 1999
TBIL
K983133 · Abbott Laboratories · Sep 1998
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
K972382 · Arrows Co., Ltd. · Sep 1998