Cleared Traditional

K761027 - AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN

K761027 is the FDA 510(k) clearance for AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN by Harleco. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K761027 · Harleco · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1976
Decision
18d
Days
Class 2
Risk

K761027 is an FDA 510(k) clearance for the AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Harleco (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 862.1110 - 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 Harleco devices

Submission Details

510(k) Number K761027 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
Combination Product No
PCCP Authorized No
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 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 171
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K761027.
UNIPAK TOTAL & DIRECT BILIRUBIN
K771092 · Harleco · Jul 1977
MANUEL BILIRUBIN REAGENT SET
K770121 · Harleco · Jan 1977
AUTO TOTAL BILIRUBIN REAGENT
K761218 · Harleco · Dec 1976
POTASSIUM SODIUM TARTRATE
K760408 · J.T. Baker Chemical Co. · Nov 1976
SODIUM NITRITE
K760409 · J.T. Baker Chemical Co. · Nov 1976
CAFFEINE DILUENT
K760406 · J.T. Baker Chemical Co. · Oct 1976