Cleared Traditional

K913384 - COLUMNMATE(TM) BETA-THAL CAT. NO. 4515

K913384 is an FDA 510(k) clearance for COLUMNMATE(TM) BETA-THAL CAT. NO. 4515, manufactured by Helena Laboratories. The device is a Class 2 Hematology device with product code JPD cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K913384 · Helena Laboratories · Hematology device
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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

FDA 510(k) Submission Details - K913384

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.

JPD Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (JPD) and FDA review panel - the closest regulatory comparables to K913384.
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
BETA THALQUIK COLUMN #5341
K823870 · Helena Laboratories · Feb 1983