Cleared Traditional

K831624 - GLUCOSE REAGENT KITS-B6370-10A

K831624 is an FDA 510(k) clearance for GLUCOSE REAGENT KITS-B6370-10A, manufactured by American Scientific Products. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K831624 · American Scientific Products · Chemistry device
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Jul 1983
Decision
47d
Days
Class 2
Risk

K831624 is an FDA 510(k) clearance for the GLUCOSE REAGENT KITS-B6370-10A. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on July 6, 1983 after a review of 47 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 American Scientific Products devices

FDA 510(k) Submission Details - K831624

510(k) Number K831624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1983
Decision Date July 06, 1983
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
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 303
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K831624.
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983
GLUCOSE REAGENT B6360-11
K831634 · American Scientific Products · Jul 1983
GLUCOSE OXIDASE/PEROXIDASE TEST
K831411 · King Diagnostics, Inc. · Jul 1983
ENZYMATIC GLUCOSE DETERMINATION
K823474 · The Dow Chemical Co. · Dec 1982
GLUCOSCAN METER MODEL II
K822699 · Lifescan, Inc. · Nov 1982
LANCER MSH GLUCOSE DIAG. KIT
K822958 · Sherwood Medical Co. · Nov 1982