Cleared Traditional

K213396 - SPIFE A1AT kit (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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.