Cleared Traditional

K924173 - HEMOCARD(TM) CONTROL

K924173 is an FDA 510(k) clearance for HEMOCARD(TM) CONTROL, manufactured by Isolab, Inc.. The device is a Class 2 Hematology device with product code JCM cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K924173 · Isolab, Inc. · Hematology device
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Dec 1992
Decision
104d
Days
Class 2
Risk

K924173 is an FDA 510(k) clearance for the HEMOCARD(TM) CONTROL. 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 December 1, 1992 after a review of 104 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K924173

510(k) Number K924173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1992
Decision Date December 01, 1992
Days to Decision 104 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
9d faster than avg
Panel avg: 113d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCM Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (JCM) and FDA review panel - the closest regulatory comparables to K924173.
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
K942222 · Isolab, Inc. · Jan 1995
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086 · Helena Laboratories · Oct 1994
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
K931234 · Isolab, Inc. · May 1993
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
K913427 · Creative Laboratory Products, Inc. · Nov 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · Bio-Rad · Jun 1991
HEMOCARD CONTROL
K910431 · Isolab, Inc. · Mar 1991