Cleared Traditional

VARIANT BETA-THALASSEMIA SHORT PROGRAM (K924122) - FDA 510(k) Clearance

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

K924122 · Bio-Rad · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
209d
Days
Class 2
Risk

K924122 is an FDA 510(k) clearance for the VARIANT BETA-THALASSEMIA SHORT PROGRAM. Classified as Hemoglobin A2 Quantitation (product code JPD), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on March 11, 1993 after a review of 209 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7400 - 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 Bio-Rad devices

Submission Details

510(k) Number K924122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1992
Decision Date March 11, 1993
Days to Decision 209 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
96d slower than avg
Panel avg: 113d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPD Hemoglobin A2 Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7400
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 - JPD Hemoglobin A2 Quantitation

All 12
Devices cleared under the same product code (JPD) and FDA review panel - the closest regulatory comparables to K924122.
VARIANT II B-THALASSEMIA
K991127 · Bio-Rad · Jun 1999
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
K923317 · Helena Laboratories · Aug 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
K923318 · Helena Laboratories · Aug 1992
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
K913384 · Helena Laboratories · Dec 1991
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · Bio-Rad · Jan 1990
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
K875102 · Bio-Rad · Feb 1988