Cleared Traditional

K842207 - WAKO B.G. PRETEST STRIPS

K842207 is the FDA 510(k) clearance for WAKO B.G. PRETEST STRIPS by Healthdyne, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K842207 · Healthdyne, Inc. · Chemistry device
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Jun 1984
Decision
22d
Days
Class 2
Risk

K842207 is an FDA 510(k) clearance for the WAKO B.G. PRETEST STRIPS. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1984 after a review of 22 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 Healthdyne, Inc. devices

Submission Details

510(k) Number K842207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date June 26, 1984
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 Chemistry 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 K842207.
SYSTEMATE GLUCOSE 67215
K843151 · Em Diagnostic Systems, Inc. · Aug 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · Boehringer Mannheim Corp. · Aug 1984
GLUCOSE-TRINDER-ADDAY KIT
K842506 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
REFLOCHECK-S
K840962 · Boehringer Mannheim Corp. · Jun 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
WAKO GLUCOSE C
K833257 · Wako Chemicals USA, Inc. · Dec 1983