Cleared Traditional

K922136 - ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP

K922136 is the FDA 510(k) clearance for ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP by Home Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 475-day FDA review.

K922136 · Home Diagnostics, Inc. · Chemistry device
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Aug 1993
Decision
475d
Days
Class 2
Risk

K922136 is an FDA 510(k) clearance for the ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIP. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Home Diagnostics, Inc. (Eatontown, US). The FDA issued a Cleared decision on August 10, 1993 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Home Diagnostics, Inc. devices

Submission Details

510(k) Number K922136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1992
Decision Date August 10, 1993
Days to Decision 475 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
387d slower than avg
Panel avg: 88d · This submission: 475d
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 197
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K922136.
GLUCOSTIX REAGENT STRIPS
K926362 · Heraeus Kulzer, Inc. · Nov 1993
GLUCOFILM TEST STRIPS
K926360 · Heraeus Kulzer, Inc. · Sep 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · Boehringer Mannheim Corp. · Sep 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · Heraeus Kulzer, Inc. · Jun 1993
HI CHEM GLUCOSE REAGENT KIT, PRODUCT NO. 88807
K925551 · Hichem Diagnostics · Apr 1993
ELITE TEST STRIPS GLUCOMETER
K924499 · Heraeus Kulzer, Inc. · Dec 1992