510(k) · Cleared

Cleared

Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa Reagent Pack

K984289510(k) TraditionalCleared Mar 12, 1999101-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

Ortho-Clinical Diagnostics, Inc. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Cleared on Mar 12, 1999 as substantially equivalent to P850048 (Beckman Coulter, Inc., 1986) after a 101-day review. Its family tree reaches back 1 generation to 1986.

Decided: Mar 12, 1999
Review: 101 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 deviceK984289 Vitros Immunodiagnostic Products Psa Calibrators, Vitros…Ortho-Clinical Diagnostics, Inc. · 1999

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)	K984289	Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic…	Ortho-Clinical Diagnostics, Inc.	1999	—

FIG. 1 — Lineage of K984289, 1986–1999Source: 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 …ate specific antigen in serum or plasma. 3. Predicate Device The VITROS Immunodiagnostic Products PSA assay is substantially equivalent to the Hybritech Tandem®-R PSA (P850048). 4. Device Description The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantit…	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?

The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.

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/K984289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984289: Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa Reagent Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984289

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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