510(k) · Cleared

Cleared

Enzymun-Test Psa

K965085510(k) TraditionalCleared Mar 19, 199790-day reviewClass II21 CFR 866.6010

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

Boehringer Mannheim Corp. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Cleared on Mar 19, 1997 as substantially equivalent to P850048 (Beckman Coulter, Inc., 1986) after a 90-day review. Its family tree reaches back 1 generation to 1986.

Decided: Mar 19, 1997
Review: 90 days
Class: Class II
Product code: LTJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P850048 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backP850048 Tandem-R Psa Immunoradiometric AssayBeckman Coulter, Inc. · 1986
This deviceK965085 Enzymun-Test PsaBoehringer Mannheim Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P850048	Tandem-R Psa Immunoradiometric Assay	Beckman Coulter, Inc.	1986	—
0 (this device)	K965085	Enzymun-Test Psa	Boehringer Mannheim Corp.	1997	—

FIG. 1 — Lineage of K965085, 1986–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LTJ? 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 LTJ device

#1 K251630 Atellica IM Total PSA II (tPSAII)score 10.6 · 1 generation · no Class I recall

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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	Applicant	Decided	Recalls
*	P850048	Tandem-R Psa Immunoradiometric Assay Summary page 1 …name: Prostate-specific antigen (PSA), immunological test system for the management of prostate cancer We claim substantial equivalence to the Hybritech Tandem®-R PSA (P850048). The Enzymun-Test PSA test principle is an ELISA/1-step sandwich assay using streptavidin technology. The assay procedure is de…	Beckman Coulter, Inc.	1986	—

Also cleared against P850048: 2 other devices →

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.
2 other devices also cite its predicate P850048.

How does its category compare?

All LTJ devices

LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTJ

3in 2025

2007high 10 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LTJ

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

Recalls per year · LTJ

1in 2025

2007high 3 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LTJ

14in 2025

2007high 109 (2011) · low 4 (2020)2025

MAUDE reports naming product code LTJ, 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	17
2008	0	—	3	57
2009	0	—	0	58
2010	0	—	2	34
2011	0	—	0	109
2012	0	—	0	101
2013	1	—	1	69
2014	0	—	0	19
2015	0	—	0	14
2016	2	—	0	8
2017	10	—	0	13
2018	7	—	0	8
2019	2	—	0	11
2020	1	—	0	4
2021	2	—	0	8
2022	0	—	0	11
2023	2	—	0	17
2024	3	—	0	8
2025	3	—	1	14
2026	3	—	0	—

What is it indicated for?

Enzyme-linked immunosorbent assay for the quantitative determination of Prostate-Specific Antigen (PSA) in serum and plasma.

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/K965085 · printed Nov 6, 2026

Cite this page

510(k) Report. “K965085: Enzymun-Test Psa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965085

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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