A1AT Genotyping Test

K192858 · Progenika Biopharma S.A., A Grifols Company · PZH · Nov 5, 2019 · Immunology

Device Facts

• Record ID: K192858
• Device Name: A1AT Genotyping Test
• Applicant: Progenika Biopharma S.A., A Grifols Company
• Product Code: PZH · Immunology
• Decision Date: Nov 5, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Indications for Use

The Progenika A1AT genotyping kit is a quantitative, polymerase chain reaction (PCR) and hybridization-based in vitro diagnostic test to be used with the Luminex 200 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 intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spot (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx model 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

Device performs quantitative genotyping of SERPINA1 gene; utilizes multiplex PCR and hybridization-based technology. Input: genomic DNA from whole blood (DBS/K2-EDTA) or saliva (buccal swabs). Process: DNA amplification/biotinylation via multiplex PCR; denaturation; hybridization to oligonucleotide probes on color-coded beads; fluorescent labeling; detection via Luminex 200 system. Output: allelic variant genotypes and associated alleles processed by A1AT Genotyping Test ANALYSIS SOFTWARE. Used in clinical laboratory settings by trained technicians. Results aid clinicians in diagnosing A1AT deficiency when combined with other clinical findings. Benefits patients by providing rapid, simultaneous identification of 14 clinically relevant variants.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess the impact of the new specimen type (buccal swabs) on device performance. No clinical data presented.

Technological Characteristics

Multiplex PCR and hybridization-based assay. Uses Luminex xMAP technology with color-coded beads. Instrumentation: Luminex 200 with xPONENT software. Reagents: PCR Master Mix, Beads Master Mix, SAPE, SAPE Dilution Buffer. DNA extraction methods include QIAamp DNA Blood Mini Kit, QIAsymphony DNA Mini Kit, and commercial lysis/neutralization solutions. Software-based analysis of fluorescent signals.

Indications for Use

Indicated for the detection of Alpha-1-Antitrypsin (A1AT) genotypes in human specimens to aid in the diagnosis of A1AT deficiency.

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 (K171868)

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

K192858

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 K171868
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.
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

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for inclusion of a new specimen type, human saliva, collected as buccal swabs using ORAcollect-Dx model OCD-100.

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 device.

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