Cleared Traditional

HEMOCARD, HEMOGLOBIN C ASSAY (K923153) - FDA 510(k) Clearance

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

K923153 · Isolab, Inc. · Hematology device
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Jan 1994
Decision
577d
Days
Class 2
Risk

K923153 is an FDA 510(k) clearance for the HEMOCARD, HEMOGLOBIN C ASSAY. Classified as Hemoglobin C (abnormal Hemoglobin Variant) (product code MLL), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 577 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Isolab, Inc. devices

Submission Details

510(k) Number K923153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1992
Decision Date January 27, 1994
Days to Decision 577 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
464d slower than avg
Panel avg: 113d · This submission: 577d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLL Hemoglobin C (abnormal Hemoglobin Variant)
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.