Cleared Traditional

GERMCO TEST R GLUCOSE TEST KIT (K810567) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810567 · Fermco Biochemics, Inc. · Chemistry device
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Mar 1981
Decision
10d
Days
Class 2
Risk

K810567 is an FDA 510(k) clearance for the GERMCO TEST R GLUCOSE TEST KIT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Fermco Biochemics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Fermco Biochemics, Inc. devices

Submission Details

510(k) Number K810567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date March 13, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 74
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K810567.
VISIDEX REAGENT STRIPS
K821179 · Miles Laboratories, Inc. · May 1982
AMES SERA-PAK GLUCOSE REAGENT
K811392 · Miles Laboratories, Inc. · May 1981
SERALYZER SYSTEM
K810639 · Miles Laboratories, Inc. · Mar 1981
SERALYZER GLUCOSE REAGENT STRIPS
K801663 · Miles Laboratories, Inc. · Aug 1980
TECHNICON C202 SYSTEM
K791989 · Technicon Instruments Corp. · Oct 1979
STATTEK-GLUCOSE LOW LEVEL
K781075 · Boehringer Mannheim Corp. · Aug 1978