Cleared Traditional

DIRECT & TOTAL BILIRUBIN SET (K855195) - FDA 510(k) Clearance

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

K855195 · Technostics Intl. · Chemistry device
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Jan 1986
Decision
19d
Days
Class 2
Risk

K855195 is an FDA 510(k) clearance for the DIRECT & TOTAL BILIRUBIN SET. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 19 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 Technostics Intl. devices

Submission Details

510(k) Number K855195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
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 71
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K855195.
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
SYSTEMATE T-BILI 67212
K843328 · Em Diagnostic Systems, Inc. · Sep 1984
SYSTEMATE D-BILI 67213
K843329 · Em Diagnostic Systems, Inc. · Sep 1984