Cleared Traditional

K821091 - ACCUCHEK BG.

K821091 is an FDA 510(k) clearance for ACCUCHEK BG., manufactured by Biodynamics Corp.. The device is a Class 2 Hematology device with product code CGA cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K821091 · Biodynamics Corp. · Hematology device
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May 1982
Decision
25d
Days
Class 2
Risk

K821091 is an FDA 510(k) clearance for the ACCUCHEK BG.. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Biodynamics Corp. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1982 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1345 - the FDA hematology device 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 Biodynamics Corp. devices

FDA 510(k) Submission Details - K821091

510(k) Number K821091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1982
Decision Date May 14, 1982
Days to Decision 25 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 113d · This submission: 25d
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 Hematology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 263
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K821091.
GLUCOSE(ENZYMATIC) REAGENT SET
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K821192 · Yellow Springs Instrument Co., Inc. · Jun 1982
ACCUDEX REAGENT STRIPS
K821247 · Miles Laboratories, Inc. · May 1982
VISIDEX REAGENT STRIPS
K821179 · Miles Laboratories, Inc. · May 1982
CHEMSTRIP UG
K820465 · Biodynamics Corp. · Mar 1982
ELECTROLYTE GEL
K813370 · Hi Chem, Inc. · Dec 1981