Cleared Traditional

REAGENTS FOR DETERM. ALBUMIN IN HUMAN (K800678) - FDA 510(k) Clearance

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

K800678 · Diagnostic Solutions, Inc. · Chemistry device
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May 1980
Decision
63d
Days
Class 2
Risk

K800678 is an FDA 510(k) clearance for the REAGENTS FOR DETERM. ALBUMIN IN HUMAN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Diagnostic Solutions, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 63 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 Diagnostic Solutions, Inc. devices

Submission Details

510(k) Number K800678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1980
Decision Date May 28, 1980
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
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 25
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K800678.
SYSTEMATE ALBUMIN
K843108 · Em Diagnostic Systems, Inc. · Aug 1984
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)
K812030 · Eastman Kodak Company · Aug 1981
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · Beckman Instruments, Inc. · Sep 1980
MULTISTAT III ALBUMIN TEST
K771475 · Instrumentation Laboratory CO · Sep 1977
A-GENT ALBUMIN
K770822 · Abbott Laboratories · Jul 1977