Cleared Traditional

K792408 - ELVI ALBUMIN

K792408 is the FDA 510(k) clearance for ELVI ALBUMIN by Volu Sol Medical Industries. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K792408 · Volu Sol Medical Industries · Chemistry device
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Dec 1979
Decision
10d
Days
Class 2
Risk

K792408 is an FDA 510(k) clearance for the ELVI ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 K792408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date December 06, 1979
Days to Decision 10 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
78d faster than avg
Panel avg: 88d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 77
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K792408.
AMES SERA-PAK ALBUMIN REAGENT KIT
K803237 · Miles Laboratories, Inc. · Jan 1981
CENTRIFICHEM ALBUMIN
K802436 · Union Carbide Corp. · Oct 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · Beckman Instruments, Inc. · Sep 1980
ALBUMIN REAGENT
K781773 · Gilford Diagnostics · Nov 1978
ULTRACHEM ALBUMIN
K780092 · Harleco · Feb 1978
MULTISTAT III ALBUMIN TEST
K771475 · Instrumentation Laboratory CO · Sep 1977