510(k) · Cleared

Cleared

Serodia TP-PA

K971502510(k) TraditionalCleared Nov 13, 1997203-day reviewClass II21 CFR 866.3830

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Scimedx Tekfile Services · GMT Antigens, Ha, Treponema Pallidum

Cleared on Nov 13, 1997 after a 203-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Nov 13, 1997
Review: 203 days
Class: Class II
Product code: GMT
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK971502 Serodia TP-PAScimedx Tekfile Services · 1997
Descendant · cites it directly · 1 of its ownK063866 Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2007 · Recalled
Descendant · 2 generations on · 0 of its ownK120439 Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all

K063866Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories · 2007 · cites it directly1descendant
K120439Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971502	Serodia TP-PA	Scimedx Tekfile Services	1997	—
+1	K063866	Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System	Bio-Rad Laboratories	2007	3
+2	K120439	Bioplex 2200 Ebv Igg and Syphilis Igg	Bio-Rad Laboratories, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2012	1	0

FIG. 1 — Lineage of K971502, 1997–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GMT? 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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063866	Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System	Bio-Rad Laboratories	2007	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?

Of its descendants, K063866 (Bio-Rad Laboratories, 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GMT devices

GMT Antigens, Ha, Treponema Pallidum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GMT

FDA has decided no GMT device since 2007.

Median 510(k) review, days · GMT

Too few GMT 510(k)s in any year since 2007 to give a median.

Recalls per year · GMT

No recall names GMT since 2007.

Adverse event reports per year · GMT

1in 2012

2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code GMT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Serodia-TP-PA is a qualitative gelatin particle agglutination assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis.- This product is not cleared or approved by the U.S. Food and Drug Administration (FDA) for use in screening blood orptasma donors.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K971502 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971502: Serodia TP-PA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971502

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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