510(k) · Cleared
ClearedLiat Strep a Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iquum, Inc. · PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Cleared on Nov 4, 2014 as substantially equivalent to DEN140005 (Quidel Corporation, 2014) after a 167-day review. Its family tree reaches back 1 generation to 2014. 8 later devices descend from it.
- Decided
- Nov 4, 2014
- Review
- 167 days
- Class
- Class II
- Product code
- PGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140005 (2014). 8 later devices descend from it, 5 citing it directly.
- Root · 1 generation backDEN140005 Lyra Direct Strep AssayQuidel Corporation · 2014
- This deviceK141338 Liat Strep a AssayIquum, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK200065 cobas Influenza A/B Nucleic acid test for use on the cobas Liat…Roche Molecular Systems, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK210234 cobas Influenza A/B & RSV Nucleic acid test for use on the cobas…Roche Molecular Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK260047 cobas Strep A Nucleic acid test for use on the cobas Liat System…Roche Molecular Systems, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK213822 cobas Influenza A/B & RSV nucleic acid test for use on the cobas…Roche Molecular Systems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK201269 Accula Strep A TestMesa Biotech, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc. · 2020 · cites it directly3descendants
- K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2021 · 2 generations on1descendant
- K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc. · 2026 · 2 generations on0descendants
- K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. · 2022 · 3 generations on0descendants
- K201269Accula Strep A TestMesa Biotech, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140005 | Lyra Direct Strep Assay | Quidel Corporation | 2014 | — |
| 0 (this device) | K141338 | Liat Strep a Assay | Iquum, Inc. | 2014 | — |
| +1 | K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas… | Roche Molecular Systems, Inc. | 2020 | — |
| +2 | K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021 | — |
| +2 | K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System… | Roche Molecular Systems, Inc. | 2026 | — |
| +3 | K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2022 | — |
| +1 | K201269 | Accula Strep A Test | Mesa Biotech, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 PGX? 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 PGX device
- #1 K260047 cobas Strep A Nucleic acid test for use on the…score 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | DEN140005 | Lyra Direct Strep Assay Our reading of the summary gave K133883, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN140005, Lyra Direct Strep Assay (Quidel Corporation), granted Apr 16, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza… | 2020 | 3 |
| K201269 | Accula Strep A Test | 2020 | 0 |
| K173398 | Xpert Xpress Strep A | 2018 | 0 |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit | 2017 | 0 |
| K172126 | Xpert Xpress Strep A | 2017 | 0 |
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?
How does its category compare?
All PGX devicesPGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PGX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PGX
85in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PGX
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PGX
1in 2022
MAUDE reports naming product code PGX, not matched to any one device; reports are not rates.
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 | 3 | — | 0 | 0 |
| 2015 | 3 | 85 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Liat™ Strep A Assay, performed on the Liat™ Analyzer, is a qualitative in vitro diagnostic test for the detection of
Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs
and symptoms of pharyngitis.
The Liat™ Strep A Assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect
Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.
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/K141338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141338: Liat Strep a Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141338
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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