Cleared Traditional

K911347 - LYPHOCHEK HEMOGLOBIN A2 CONTROL

K911347 is the FDA 510(k) clearance for LYPHOCHEK HEMOGLOBIN A2 CONTROL by Bio-Rad. It is a Class 2 Hematology device (product code JCM) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K911347 · Bio-Rad · Hematology device
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Jun 1991
Decision
75d
Days
Class 2
Risk

K911347 is an FDA 510(k) clearance for the LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL. Classified as Control, Hemoglobin, Abnormal (product code JCM), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 75 days - a notably fast clearance 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: 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 Bio-Rad devices

Submission Details

510(k) Number K911347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1991
Decision Date June 10, 1991
Days to Decision 75 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 113d · This submission: 75d
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 7
Devices cleared under the same product code (JCM) and FDA review panel - the closest regulatory comparables to K911347.
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
HEMOCARD(TM) CONTROL
K924173 · Isolab, Inc. · Dec 1992
HEMOCARD CONTROL
K910431 · Isolab, Inc. · Mar 1991
HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
K820787 · Helena Laboratories · Apr 1982