Cleared Traditional

K761026 - AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL

K761026 is the FDA 510(k) clearance for AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL by Harleco Diagnostics. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K761026 · Harleco Diagnostics · Chemistry device
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Nov 1976
Decision
18d
Days
Class 2
Risk

K761026 is an FDA 510(k) clearance for the AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on November 30, 1976 after a review of 18 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 Diagnostics devices

Submission Details

510(k) Number K761026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1976
Decision Date November 30, 1976
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
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 78
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K761026.
ULTRACHEM ALBUMIN
K770816 · Harleco · Jul 1977
A-GENT ALBUMIN
K770822 · Abbott Laboratories · Jul 1977
MT II SYSTEM - SERUM ALBUMIN
K761329 · Technicon Instruments Corp. · Mar 1977
AUTO-ALBUMIN REAG FOR ABBOTT ABA-100
K761028 · Harleco · Nov 1976
BROMCRESOL GREEN
K760543 · Fisher Scientific Co., LLC · Nov 1976
TEST, SEROSONIC ALBUMIN
K760355 · Mallinckrodt Critical Care · Oct 1976