Cleared Traditional

QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (K942222) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942222 · Isolab, Inc. · Hematology device
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Jan 1995
Decision
259d
Days
Class 2
Risk

K942222 is an FDA 510(k) clearance for the QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS. Classified as Control, Hemoglobin, Abnormal (product code JCM), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 259 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7415 - 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 K942222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1994
Decision Date January 20, 1995
Days to Decision 259 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 113d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCM Control, Hemoglobin, Abnormal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
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 - JCM Control, Hemoglobin, Abnormal

All 11
Devices cleared under the same product code (JCM) and FDA review panel - the closest regulatory comparables to K942222.
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
K983704 · Roche Diagnostic Systems, Inc. · Feb 1999
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086 · Helena Laboratories · Oct 1994
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · Bio-Rad · Jun 1991
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
K820787 · Helena Laboratories · Apr 1982