510(k) · Cleared
ClearedA1AT Genotyping Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progenika Biopharma S.A., A Grifols Company · PZH Serpina1 Variant Detection System
Cleared on May 13, 2021 as substantially equivalent to K192858 (Progenika Biopharma S.A., A Grifols Company, 2019) after a 29-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- May 13, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- PZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063498 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK063498 Hydragel 18 A1AT Isofocusing Kit (PN 4356)Sebia · 2007
- 2 generations backK171868 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2017
- 1 generation backK192858 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2019
- This deviceK211115 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063498 | Hydragel 18 A1AT Isofocusing Kit (PN 4356) | Sebia | 2007 | — |
| −2 | K171868 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2017 | — |
| −1 | K192858 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2019 | — |
| 0 (this device) | K211115 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192858 | A1AT Genotyping TestSummary page 5…ounts of the same reagent components are provided in each case). G. Substantial Equivalence Information: Predicate Device: A1AT Genotyping Test 510(k) number: K192858 Applicant: Progenika Biopharma S.A. Page 2 of 9 Main conclusion… | 2019 |
| † | K171868 | A1AT Genotyping Test | 2017 |
| † | K152464 | ORAcollect.Dx | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All PZH devicesPZH Serpina1 Variant Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PZH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PZH
Too few PZH 510(k)s in any year since 2007 to give a median.
Recalls per year · PZH
No recall names PZH since 2007.
Adverse event reports per year · PZH
No MAUDE report names PZH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 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 SERPINALI. The test is intended for use with genomic DNA extracted from human whole blood samples…
Read the full statement (130 words)
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 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 SERPINALI. 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211115 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211115: A1AT Genotyping Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211115
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026