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 Nov 11, 2017 as substantially equivalent to K063498 (Sebia, 2007) after a 142-day review. Its family tree reaches back 1 generation to 2007. 2 later devices descend from it.
- Decided
- Nov 11, 2017
- Review
- 142 days
- Class
- Class II
- Product code
- PZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063498 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK063498 Hydragel 18 A1AT Isofocusing Kit (PN 4356)Sebia · 2007
- This deviceK171868 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2017
- Descendant · cites it directly · 1 of its ownK192858 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2019
- Descendant · 2 generations on · 0 of its ownK211115 A1AT Genotyping TestProgenika Biopharma S.A., A Grifols Company · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063498 | Hydragel 18 A1AT Isofocusing Kit (PN 4356) | Sebia | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | K211115 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
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.
Top candidate predicates for a new PZH device
- #1 K211115 A1AT Genotyping Testscore 1.9 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K063498 | Hydragel 18 A1AT Isofocusing Kit (PN 4356)Summary page 5…e same reagent components are provided in each case). G. Substantial Equivalence Information: Predicate Device: HYDRAGEL 18 A1AT ISOFOCUSING Kit 510(k) number: k063498 Applicant: SEBIA, Inc. Main conclusion: Although technologically different (isoelectrofocusing vs. PCR/hybridization bas… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192858 | A1AT Genotyping Test | 2019 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K192858 (Progenika Biopharma S.A., A Grifols Company, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PZH devicesPZH Serpina1 Variant Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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…
Read the full statement (118 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 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. 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 as stated in the FDA summary.
https://510kreport.com/device/K171868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171868: A1AT Genotyping Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171868
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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