Cleared Traditional

K801071 - LANCER GLUCOSE RATE REAGENT KIT

K801071 is an FDA 510(k) clearance for LANCER GLUCOSE RATE REAGENT KIT, manufactured by Sherwood Medical Industries. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801071 · Sherwood Medical Industries · Chemistry device
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May 1980
Decision
17d
Days
Class 2
Risk

K801071 is an FDA 510(k) clearance for the LANCER GLUCOSE RATE REAGENT KIT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on May 23, 1980 after a review of 17 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 Sherwood Medical Industries devices

FDA 510(k) Submission Details - K801071

510(k) Number K801071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1980
Decision Date May 23, 1980
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
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 301
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K801071.
GLUCOSE (TRINDER) REAGENT
K801600 · Gilford Diagnostics · Aug 1980
SERALYZER GLUCOSE REAGENT STRIPS
K801663 · Miles Laboratories, Inc. · Aug 1980
REAGENT FOR DETERM. GLUCOSE IN H/SERUM
K800687 · Diagnostic Solutions, Inc. · May 1980
GLUCOSE OXIDASE REAGENT
K800589 · Nobel Scientific Industries, Inc. · Apr 1980
LINEAR ENZYMATIC GLUCOSE SYSTEM
K800200 · Simmler, Inc. · Feb 1980
GLUCOSE OXIDASE REAGENT KIT
K800070 · Fisher Scientific Co., LLC · Feb 1980