Cleared Traditional

K761148 - REFLOMAT/REFLOTEST SYSTEM

K761148 is an FDA 510(k) clearance for REFLOMAT/REFLOTEST SYSTEM, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K761148 · Boehringer Mannheim Corp. · Chemistry device
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Feb 1977
Decision
77d
Days
Class 2
Risk

K761148 is an FDA 510(k) clearance for the REFLOMAT/REFLOTEST SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on February 11, 1977 after a review of 77 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K761148

510(k) Number K761148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1976
Decision Date February 11, 1977
Days to Decision 77 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
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

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 316
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K761148.
TRENDAR
K771000 · Hi Chem, Inc. · Jul 1977
GLUCOSE TRINDER, ENZYMATIC
K770317 · Icn Pharmaceuticals, Inc. · Mar 1977
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200 · Beckman Instruments, Inc. · Feb 1977
GLUCOSE ANALYZER 2
K761060 · Beckman Instruments, Inc. · Jan 1977
GLUCOSE OXIDASE REAGENT SYSTEM
K761181 · Nobel Scientific Industries, Inc. · Dec 1976
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
K761153 · Advanced Biomedical Methods, Inc. · Dec 1976