Cleared Traditional

K213396 - SPIFE A1AT kit

K213396 is an FDA 510(k) clearance for SPIFE A1AT kit, manufactured by Helena Laboratories, Corp.. The device is a Class 2 Immunology device with product code OBZ cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K213396 · Helena Laboratories, Corp. · Immunology device
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Oct 2022
Decision
360d
Days
Class 2
Risk

K213396 is an FDA 510(k) clearance for the SPIFE A1AT kit. Classified as Alpha-1-antitrypsin Kit, Qualitative Phenotype (product code OBZ), Class II - Special Controls.

Submitted by Helena Laboratories, Corp. (Beaumont, US). The FDA issued a Cleared decision on October 13, 2022 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - the FDA immunology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories, Corp. devices

FDA 510(k) Submission Details - K213396

510(k) Number K213396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2021
Decision Date October 13, 2022
Days to Decision 360 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
256d slower than avg
Panel avg: 104d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OBZ Device Classification - Class 2, Special Controls

Product Code OBZ Alpha-1-antitrypsin Kit, Qualitative Phenotype
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
Definition 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.
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 Immunology devices follow this clearance model.