Cleared Traditional

K821091 - ACCUCHEK BG.

K821091 is the FDA 510(k) clearance for ACCUCHEK BG. by Biodynamics Corp.. It is a Class 2 Hematology device (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

Submission Details

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.

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 Hematology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 127
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K821091.
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983
LANCER MSH GLUCOSE DIAG. KIT
K822958 · Sherwood Medical Co. · Nov 1982
ACCUDEX REAGENT STRIPS
K821247 · Miles Laboratories, Inc. · May 1982
VISIDEX REAGENT STRIPS
K821179 · Miles Laboratories, Inc. · May 1982
ACR ENZYMATIC GLUCOSE OXIDASE
K812258 · Harleco · Aug 1981
AMES SERA-PAK GLUCOSE REAGENT
K811392 · Miles Laboratories, Inc. · May 1981