Cleared Traditional

COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 (K913384) - FDA 510(k) Clearance

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

K913384 · Helena Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
141d
Days
Class 2
Risk

K913384 is an FDA 510(k) clearance for the COLUMNMATE(TM) BETA-THAL CAT. NO. 4515. Classified as Hemoglobin A2 Quantitation (product code JPD), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 17, 1991 after a review of 141 days - within the typical 510(k) review window.

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 Helena Laboratories devices

Submission Details

510(k) Number K913384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date December 17, 1991
Days to Decision 141 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
28d slower than avg
Panel avg: 113d · This submission: 141d
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 K913384.
VARIANT II B-THALASSEMIA
K991127 · Bio-Rad · Jun 1999
VARIANT BETA-THALASSEMIA SHORT PROGRAM
K924122 · Bio-Rad · Mar 1993
COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
K923317 · Helena Laboratories · Aug 1992
COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
K923318 · Helena Laboratories · Aug 1992
HEMOGLOBIN A2 MICRO COLUMN TEST
K896168 · Bio-Rad · Jan 1990
DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
K875102 · Bio-Rad · Feb 1988