510(k) · Cleared
Recalled · Class II · 2023binx io CT/NG Assay and binx io CT/NG System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binx Health, Inc. · QEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections
Cleared on Apr 27, 2020 as substantially equivalent to K191352 (Binx Health, Inc., 2019) after a 56-day review. Its family tree reaches back 4 generations to 2001. It has been recalled once.
- Decided
- Apr 27, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- QEP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003395 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK003395 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2001 · Recalled
- 3 generations backK081825 BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO · 2008 · Recalled
- 2 generations backK091730 BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2009 · Recalled
- 1 generation backK191352 binx health io CT/NG AssayBinx Health, Inc. · 2019
- This deviceK200533 binx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003395 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2001 | 1 |
| −3 | K081825 | BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay | Becton, Dickinson & CO | 2008 | 1 |
| −2 | K091730 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna Assay | Becton, Dickinson & CO | 2009 | 1 |
| −1 | K191352 | binx health io CT/NG Assay | Binx Health, Inc. | 2019 | — |
| 0 (this device) | K200533 | binx io CT/NG Assay and binx io CT/NG System | Binx Health, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 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 QEP? 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 QEP device
- #1 K260917 cobas CT/NG for use on the cobas…score 13.7 · 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 |
|---|---|---|---|
| * | K191352 | binx health io CT/NG AssaySummary page 3…logy REQUESTED CLIA Moderate Complexity CLASSIFICATION: PREDICATE DEVICES: binx health io CT/NG Assay for female vaginal swab (K191352) INTENDED USE: The binx health io CT/NG Assay, when tested using the binx health io Instrum… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 29, 2023 | Class II | Z-1626-2023 | Under Investigation by firm | May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
How does its category compare?
All QEP devicesQEP Nucleic Acid Detection System For Non-Viral Microorganism (S) Causing Sexually Transmitted Infections: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QEP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QEP
268in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QEP
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QEP
9in 2025
MAUDE reports naming product code QEP, 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 5 | 85 | 0 | 0 |
| 2020 | 3 | 46 | 0 | 0 |
| 2021 | 3 | 521 | 0 | 1 |
| 2022 | 3 | 438 | 0 | 1 |
| 2023 | 3 | 325 | 0 | 8 |
| 2024 | 0 | — | 3 | 8 |
| 2025 | 4 | 268 | 0 | 9 |
| 2026 | 3 | 171 | 0 | — |
What is it indicated for?
The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA by polymerase chain reaction. The binx health io CT/NG Assay is intended for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a…
Read the full statement (113 words)
The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA by polymerase chain reaction. The binx health io CT/NG Assay is intended for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a clinical setting, or male urine specimens, as an aid in the diagnosis of symptomatic or asymptomatic Chlamydia trachomatis and/or Neisseria gonorrhoeae infection. For a symptomatic male patient with a chlamydia negative test result, further testing with a laboratory-based molecular test is recommended.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200533 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200533: binx io CT/NG Assay and binx io CT/NG System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200533
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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