Cleared Traditional

K881166 - DIRECT BILIRUBIN PROCEDURE

K881166 is the FDA 510(k) clearance for DIRECT BILIRUBIN PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K881166 · Data Medical Associates, Inc. · Chemistry device
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Apr 1988
Decision
41d
Days
Class 2
Risk

K881166 is an FDA 510(k) clearance for the DIRECT BILIRUBIN PROCEDURE. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on April 28, 1988 after a review of 41 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K881166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date April 28, 1988
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
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 K881166.
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · Abbott Laboratories · Aug 1988
BILIRUBIN (DIRECT)
K881172 · Tech-Co, Inc. · Jun 1988
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · Technicon Instruments Corp. · Jun 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · Abbott Laboratories · Apr 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.
K880395 · Data Medical Associates, Inc. · Mar 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880396 · Data Medical Associates, Inc. · Mar 1988