510(k) · Cleared

Cleared

Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225, 33229

K974816510(k) TraditionalCleared Feb 20, 199859-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

Beckman Instruments, Inc. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Cleared on Feb 20, 1998 as substantially equivalent to P850048 (Beckman Coulter, Inc., 1986) after a 59-day review. Its family tree reaches back 1 generation to 1986.

Decided: Feb 20, 1998
Review: 59 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 deviceK974816 Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer…Beckman Instruments, Inc. · 1998

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)	K974816	Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225…	Beckman Instruments, Inc.	1998	—

FIG. 1 — Lineage of K974816, 1986–1998Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	P850048	Tandem-R Psa Immunoradiometric Assay Summary page 1 …55318 Contact Person: Ellen Voss, M.S. Predicate Device Tandem®-R PSA Immunoradiometric Assay Hybritech, Inc. P. O. Box 269006 San Diego, CA 92196-9006 PMA Number: P850048 Device Description The ACCESS® PSA Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay Sy…	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 Access® PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of prostate-specific antigen (PSA) in human serum using the ACCESs Immunoassay System. PSA measured by the ACCEss PSA Immunoassay, is used as an aid in the manhagement 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/K974816 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974816: Access (R) Psa Reagents on the Access (R) Immunoassay Analyzer 33220, 33225, 33229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974816

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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