Cleared Traditional

K921681 - CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL

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

K921681 · Isolab, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K921681

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.

GGM Device Classification - Class 2, Special Controls

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 13
Devices cleared under the same product code (GGM) and FDA review panel - the closest regulatory comparables to K921681.
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · R&D Systems, Inc. · Nov 1999
HEMOCUE HEMOTROL
K964052 · Direct Solutions · Nov 1996
HEMOCUE HEMOLIN
K963908 · Direct Solutions · Oct 1996
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