Cleared Traditional

K780092 - ULTRACHEM ALBUMIN

K780092 is the FDA 510(k) clearance for ULTRACHEM ALBUMIN by Harleco. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K780092 · Harleco · Chemistry device
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Feb 1978
Decision
20d
Days
Class 2
Risk

K780092 is an FDA 510(k) clearance for the ULTRACHEM ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on February 7, 1978 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 Harleco devices

Submission Details

510(k) Number K780092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1978
Decision Date February 07, 1978
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 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 K780092.
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · Beckman Instruments, Inc. · Sep 1980
ELVI ALBUMIN
K792408 · Volu Sol Medical Industries · Dec 1979
ALBUMIN REAGENT
K781773 · Gilford Diagnostics · Nov 1978
MULTISTAT III ALBUMIN TEST
K771475 · Instrumentation Laboratory CO · Sep 1977
UNIPAK ALBUMIN
K771094 · Harleco · Jul 1977
ULTRACHEM ALBUMIN
K770816 · Harleco · Jul 1977