510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213396Substantially Equivalent

SPIFE A1AT kit

Helena Laboratories, Corp., Beaumont TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K213396 is the FDA 510(k) clearance record for SPIFE A1AT kit, a class II device, cleared for Helena Laboratories, Corp. on under FDA product code OBZ (Alpha-1-Antitrypsin Kit, Qualitative Phenotype). FDA's definition for product code OBZ reads: "The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only". FDA records list 282 510(k) clearances for Helena Laboratories, Corp., from to . As of , FDA records show no recalls naming K213396.

Clearance record

Decision date
Received
(360 days to decision)
Product code
OBZ Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Regulation
21 CFR 866.5130
Device class
Class II
Review panel
Immunology
Applicant
Helena Laboratories, Corp. 1530 Lindbergh Dr., Beaumont TX
510(k) summary
Statement
Third party review
No

Clearances, product code OBZ

Trailing 12 months

FDA records hold no clearances under product code OBZ in the trailing twelve months.

FDA records show no clearances under product code OBZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OBZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260