Cleared Traditional

K921681 - CRITERION

K921681 is the FDA 510(k) clearance for CRITERION by Isolab, Inc.. It is a Class 2 Hematology device (product code GGM) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K921681 · Isolab, Inc. · Hematology device
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Nov 1992
Decision
223d
Days
Class 2
Risk

K921681 is an FDA 510(k) clearance for the CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL. Classified as Control, Hemoglobin (product code GGM), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on November 17, 1992 after a review of 223 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Isolab, Inc. devices

Submission Details

510(k) Number K921681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1992
Decision Date November 17, 1992
Days to Decision 223 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 113d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGM Control, Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - GGM Control, Hemoglobin

All 11
Devices cleared under the same product code (GGM) and FDA review panel - the closest regulatory comparables to K921681.
GLYCOHEMOSURE HBA1C CONTROL
K032791 · Quantimetrix Corp. · Oct 2003
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · Bio-Rad · Nov 2000
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · R&D Systems, Inc. · Nov 1999
HGB-CONTROL SET/MULTIPLE
K893985 · R&D Systems, Inc. · Aug 1989
PRECINORM HB
K852136 · Boehringer Mannheim Corp. · Jul 1985
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
K800296 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1980