Cleared Traditional

K863056 - BILIRUBIN TOTAL

K863056 is an FDA 510(k) clearance for BILIRUBIN TOTAL, manufactured by J. D. Assoc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K863056 · J. D. Assoc. · Chemistry device
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Nov 1986
Decision
104d
Days
Class 2
Risk

K863056 is an FDA 510(k) clearance for the BILIRUBIN TOTAL. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J. D. Assoc. devices

FDA 510(k) Submission Details - K863056

510(k) Number K863056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date November 24, 1986
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
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 K863056.
BILIRUBIN TESTER
K870095 · Wako Chemicals USA, Inc. · Jun 1987
REAGENTS 1263,1273,1284,1425,014301,053583
K871531 · American Research Products Co. · May 1987
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
K871530 · American Research Products Co. · May 1987
DIRECT BILIRUBIN PROCEDURE
K863265 · Data Medical Associates, Inc. · Oct 1986
BILIRUBIN TOTAL DIRECT
K863057 · J. D. Assoc. · Sep 1986
TOTAL BILIRUBIN PROCEDURE
K863262 · Data Medical Associates, Inc. · Sep 1986