Cleared Traditional

K780545 - SR-PLUS DIRECT CHOLESTEROL TEST

K780545 is an FDA 510(k) clearance for SR-PLUS DIRECT CHOLESTEROL TEST, manufactured by Stanbio Laboratory. The device is a Class 1 Chemistry device with product code CGO cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K780545 · Stanbio Laboratory · Chemistry device
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May 1978
Decision
53d
Days
Class 1
Risk

K780545 is an FDA 510(k) clearance for the SR-PLUS DIRECT CHOLESTEROL TEST. Classified as Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol (product code CGO), Class I - General Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K780545

510(k) Number K780545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1978
Decision Date May 26, 1978
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

CGO Device Classification - Class 1, General Controls

Product Code CGO Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGO Lieberman-burchard/abell-kendall, Colorimetric, Cholesterol

All 8
Devices cleared under the same product code (CGO) and FDA review panel - the closest regulatory comparables to K780545.
CHOLESTEROL REAGENT
K810090 · Anco Medical Reagents & Assoc. · Jan 1981
REAGENTS FOR DETERM. CHOLESTEROL/SERUM
K800682 · Diagnostic Solutions, Inc. · May 1980
CHOLESTEROL DET. IN SERUM
K781611 · Fisher Scientific Co., LLC · Oct 1978
CHOLESTEROL
K771833 · Gamma Enterprises, Inc. · Oct 1977
CHOLESTEROL REAGENT
K771313 · Mallinckrodt Critical Care · Aug 1977
UNIPAK CHOLESTEROL
K771093 · Harleco · Jul 1977