510(k) · Cleared
ClearedPANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Analysis, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Nov 19, 2014 as substantially equivalent to K033786 (Ibl GmbH, 2004) after a 390-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Nov 19, 2014
- Review
- 390 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033786 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK033786 Luminescent Immunoassay Kit for the Detection of Testosterone in…Ibl GmbH · 2004
- This deviceK133303 PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample…Bio-Analysis, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033786 | Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and… | Ibl GmbH | 2004 | — |
| 0 (this device) | K133303 | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device | Bio-Analysis, Inc. | 2014 | — |
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 JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 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 |
|---|---|---|---|
| * | K033786 | Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and SalivaSummary page 4…cate Device: Device Name: Testosterone Luminescence Immunoassay Company: IBL International GMBH 510(k) Reference: K033786 1. Device Description: a. Test principle The Pantex Salivary Direct Testosterone EIA kit, Cat # 635 is based on the co… | 2004 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
The Pantex Salivary Direct Testosterone EIA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males, and females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and andrenogential syndromes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133303: PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133303
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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