Cleared Traditional

K861413 - BILIRUBIN*SR (TOTAL) LIQUID STABLE REAG...

K861413 is the FDA 510(k) clearance for BILIRUBIN*SR (TOTAL) LIQUID STABLE REAG... by Medical Analysis Systems, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K861413 · Medical Analysis Systems, Inc. · Chemistry device
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Apr 1986
Decision
9d
Days
Class 2
Risk

K861413 is an FDA 510(k) clearance for the BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on April 24, 1986 after a review of 9 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K861413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date April 24, 1986
Days to Decision 9 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
79d faster than avg
Panel avg: 88d · This submission: 9d
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 168
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K861413.
TOTAL BILIRUBIN TEST KIT
K861998 · Ciba Corning Diagnostics Corp. · Jun 1986
DIRECT BILIRUBIN PROCEDURE
K861671 · Data Medical Associates, Inc. · Jun 1986
TOTAL BILIRUBIN PROCEDURE
K861651 · Data Medical Associates, Inc. · May 1986
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
K861094 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1986
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
K861095 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1986
A-GENT LIQUID TOTAL BILIRUBIN
K860424 · Abbott Laboratories · Apr 1986