Cleared Traditional

K792415 - ELVI TOTAL BILIRUBIN & FRACTIONS

K792415 is the FDA 510(k) clearance for ELVI TOTAL BILIRUBIN & FRACTIONS by Volu Sol Medical Industries. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K792415 · Volu Sol Medical Industries · Chemistry device
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Dec 1979
Decision
11d
Days
Class 2
Risk

K792415 is an FDA 510(k) clearance for the ELVI TOTAL BILIRUBIN & FRACTIONS. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 7, 1979 after a review of 11 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 Volu Sol Medical Industries devices

Submission Details

510(k) Number K792415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date December 07, 1979
Days to Decision 11 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
77d faster than avg
Panel avg: 88d · This submission: 11d
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 K792415.
KING DIAGNOSTICS TOTAL BILIRUBIN TEST
K811881 · King Diagnostics, Inc. · Jul 1981
STANBIO BILIRUBIN TEST SET
K810055 · Stanbio Laboratory · Feb 1981
CAFFEINE REAGENT DIAZO COLORIMETRY
K802630 · American Monitor Corp. · Nov 1980
ELVI TOTAL BILIRUBIN & FRACTIONS
K792411 · Volu Sol Medical Industries · Dec 1979
BILIRUBIN, DINGLE VALVE DPD
K781921 · Boehringer Mannheim Corp. · Jan 1979
BILIRUBIN DETERMINTAITON IN SERUM
K781610 · Fisher Scientific Co., LLC · Oct 1978