Cleared Traditional

A-GENT ALBUMIN (K770822) - FDA 510(k) Clearance

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

K770822 · Abbott Laboratories · Chemistry device
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Jul 1977
Decision
68d
Days
Class 2
Risk

K770822 is an FDA 510(k) clearance for the A-GENT ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 68 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 Abbott Laboratories devices

Submission Details

510(k) Number K770822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1977
Decision Date July 11, 1977
Days to Decision 68 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
20d faster than avg
Panel avg: 88d · This submission: 68d
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 42
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K770822.
MULTISTAT III ALBUMIN TEST
K771475 · Instrumentation Laboratory CO · Sep 1977
UNIPAK ALBUMIN
K771094 · Harleco · Jul 1977
ULTRACHEM ALBUMIN
K770816 · Harleco · Jul 1977
MT II SYSTEM - SERUM ALBUMIN
K761329 · Technicon Instruments Corp. · Mar 1977
AUTO-ALBUMIN REAG FOR ABBOTT ABA-100
K761028 · Harleco · Nov 1976