Cleared Traditional

HEMOCARD CONTROL HB-AA, AE, FAA, FAE (K931234) - FDA 510(k) Clearance

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

K931234 · Isolab, Inc. · Chemistry device
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May 1993
Decision
62d
Days
Class 2
Risk

K931234 is an FDA 510(k) clearance for the HEMOCARD CONTROL HB-AA, AE, FAA, FAE. 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 May 11, 1993 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7415 - 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 Isolab, Inc. devices

Submission Details

510(k) Number K931234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date May 11, 1993
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 Chemistry 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 K931234.
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