Cleared Traditional

K781773 - ALBUMIN REAGENT

K781773 is an FDA 510(k) clearance for ALBUMIN REAGENT, manufactured by Gilford Diagnostics. The device is a Class 2 Pathology device with product code CIX cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K781773 · Gilford Diagnostics · Pathology device
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Nov 1978
Decision
40d
Days
Class 2
Risk

K781773 is an FDA 510(k) clearance for the ALBUMIN REAGENT. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Gilford Diagnostics (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.1035 - the FDA pathology device 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 Gilford Diagnostics devices

FDA 510(k) Submission Details - K781773

510(k) Number K781773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1978
Decision Date November 22, 1978
Days to Decision 40 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 77d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

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 Pathology devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 106
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K781773.
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · Beckman Instruments, Inc. · Sep 1980
REAGENTS FOR DETERM. ALBUMIN IN HUMAN
K800678 · Diagnostic Solutions, Inc. · May 1980
ELVI ALBUMIN
K792408 · Volu Sol Medical Industries · Dec 1979
ULTRACHEM ALBUMIN
K780092 · Harleco · Feb 1978
ALBUMIN
K771828 · Gamma Enterprises, Inc. · Oct 1977
MULTISTAT III ALBUMIN TEST
K771475 · Instrumentation Laboratory CO · Sep 1977