Cleared Traditional

K771621 - MULTISTAT III, TOTAL BILIRUBIN TEST

K771621 is an FDA 510(k) clearance for MULTISTAT III, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K771621 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
19d
Days
Class 2
Risk

K771621 is an FDA 510(k) clearance for the MULTISTAT III, TOTAL BILIRUBIN TEST. Classified as Diazo Colorimetry, Bilirubin (product code CIG), 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 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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 - K771621

510(k) Number K771621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1977
Decision Date September 13, 1977
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 215
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K771621.
BILIRUBIN DETERMINTAITON IN SERUM
K781610 · Fisher Scientific Co., LLC · Oct 1978
ULTRACHEM T-BILI 64971 GILFORD 3500
K780524 · Harleco · May 1978
TOTAL BILIRUBIN
K771840 · Gamma Enterprises, Inc. · Oct 1977
UNIPAK TOTAL BILIRUBIN
K771089 · Harleco · Jul 1977
UNIPAK TOTAL & DIRECT BILIRUBIN
K771092 · Harleco · Jul 1977
BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR.
K770458 · Icn Pharmaceuticals, Inc. · May 1977