Cleared Traditional

K810055 - STANBIO BILIRUBIN TEST SET

K810055 is the FDA 510(k) clearance for STANBIO BILIRUBIN TEST SET by Stanbio Laboratory. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K810055 · Stanbio Laboratory · Chemistry device
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Feb 1981
Decision
20d
Days
Class 2
Risk

K810055 is an FDA 510(k) clearance for the STANBIO BILIRUBIN TEST SET. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on February 2, 1981 after a review of 20 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 Stanbio Laboratory devices

Submission Details

510(k) Number K810055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date February 02, 1981
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 154
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K810055.
ULTRACHEM T-BILI, #64971
K821462 · Emd Chemicals, Inc. · Jun 1982
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
K812784 · Beckman Instruments, Inc. · Oct 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · Beckman Instruments, Inc. · Oct 1981
CAFFEINE REAGENT DIAZO COLORIMETRY
K802630 · American Monitor Corp. · Nov 1980
ELVI TOTAL BILIRUBIN & FRACTIONS
K792415 · Volu Sol Medical Industries · Dec 1979
ELVI TOTAL BILIRUBIN & FRACTIONS
K792411 · Volu Sol Medical Industries · Dec 1979