Cleared Traditional

K771475 - MULTISTAT III ALBUMIN TEST

K771475 is an FDA 510(k) clearance for MULTISTAT III ALBUMIN TEST, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K771475 · Instrumentation Laboratory CO · Chemistry device
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Sep 1977
Decision
40d
Days
Class 2
Risk

K771475 is an FDA 510(k) clearance for the MULTISTAT III ALBUMIN TEST. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977 after a review of 40 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K771475

510(k) Number K771475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1977
Decision Date September 13, 1977
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · 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 Chemistry devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 105
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K771475.
ALBUMIN REAGENT
K781773 · Gilford Diagnostics · Nov 1978
ULTRACHEM ALBUMIN
K780092 · Harleco · Feb 1978
ALBUMIN
K771828 · Gamma Enterprises, Inc. · Oct 1977
ALBUMIN TEST, HMA ALBUMIN TEST
K771259 · Hycel, Inc. · Aug 1977
UNIPAK ALBUMIN
K771094 · Harleco · Jul 1977
ULTRACHEM ALBUMIN
K770816 · Harleco · Jul 1977