A1AT Genotyping Test

K211115 · Progenika Biopharma S.A., A Grifols Company · PZH · May 13, 2021 · Immunology

Device Facts

• Record ID: K211115
• Device Name: A1AT Genotyping Test
• Applicant: Progenika Biopharma S.A., A Grifols Company
• Product Code: PZH · Immunology
• Decision Date: May 13, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Indications for Use

The Progenika A1AT genotyping kit is a qualitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminex 200TM instrument (with xPONENT® software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect·Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.

Device Story

The A1AT Genotyping Test is an in vitro diagnostic assay for identifying 14 allelic variants in the SERPINA1 gene. Input samples include genomic DNA from human whole blood (DBS or K2-EDTA) or saliva (buccal swabs). The process involves multiplex PCR amplification and biotinylation of DNA, followed by hybridization to oligonucleotide probes on color-coded beads (Luminex xMAP technology). Hybridized DNA is labeled with a fluorescent conjugate and detected by the Luminex 200 system. The A1AT Genotyping Test Analysis Software processes raw data to convert allelic variant genotypes into associated alleles based on literature. The device is used in clinical laboratory settings by trained personnel. Results are interpreted by healthcare providers alongside clinical findings to aid in diagnosing A1AT deficiency. The software update (v1.0.8.16) is the primary modification from the predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of the MFI ratio range adjustment for the software algorithm.

Technological Characteristics

Uses Luminex xMAP technology; multiplex PCR amplification and hybridization to oligonucleotide probes on color-coded beads. Fluorescent detection via Luminex 200 system. Software-based analysis of allelic variants. Reagents include PCR Master Mix, Beads Master Mix, SAPE, and SAPE Dilution Buffer. Compatible with genomic DNA from whole blood (DBS/K2-EDTA) or saliva (buccal swabs).

Indications for Use

Indicated for qualitative detection of SERPINA1 gene mutations (PI*S and PI*Z alleles) in human genomic DNA from whole blood to aid in diagnosis of Alpha-1-Antitrypsin deficiency. For professional use in clinical laboratories.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.

Predicate Devices

• A1AT Genotyping Test (K192858)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K211115

B Applicant
Progenika Biopharma S.A., A Grifols Company

C Proprietary and Established Names
A1AT Genotyping Test

D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PZH | Class II | 21 CFR 866.5130 - Alpha-1-Antitrypsin Immunological Test System | IM - Immunology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device is A1AT Genotyping Test and K192858.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

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3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for a re-adjustment of the Median Fluorescence Intensity (MFI) ratio range for Probe Set 10 that is used by the A1AT Genotyping Test Analysis Software to assign genotype results associated with the allelic variant c.863A>T corresponding to PI*S.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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