510(k) · Cleared

Cleared

Immulite 2000 Free Psa Calibration Verification Material

K133816510(k) TraditionalCleared Jun 24, 2014190-day reviewClass I21 CFR 862.1660

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

Siemens Healthcare Diagnostics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Jun 24, 2014 as substantially equivalent to K131536 (Siemens Healthcare Diagnostics, Inc., 2013) after a 190-day review. Its family tree reaches back 3 generations to 2000.

Decided: Jun 24, 2014
Review: 190 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K993210 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK993210 Access Hybritech Free Psa QC, Model 37219Beckman Coulter, Inc. · 2000
2 generations backK112603 Access Hybritech P2PSA QC on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2011
1 generation backK131536 Immulite 2000 Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2013
This deviceK133816 Immulite 2000 Free Psa Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K993210	Access Hybritech Free Psa QC, Model 37219	Beckman Coulter, Inc.	2000	—
−2	K112603	Access Hybritech P2PSA QC on the Access Immunoassay Systems	Beckman Coulter, Inc.	2011	—
−1	K131536	Immulite 2000 Psa Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2013	—
0 (this device)	K133816	Immulite 2000 Free Psa Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2014	—

FIG. 1 — Lineage of K133816, 2000–2014Source: 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 JJX? 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

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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
*	K131536	Immulite 2000 Psa Calibration Verification Material Summary page 1 …hemistry (75) Panel: IMMULITE® 2000 PSA Calibration Verification Material 3. Predicate Device Name Predicate 510(k) No: K13 1536 4. Device Description: IMMULITE®'2000 Free PSA Calibration Verification Material…	Siemens Healthcare Diagnostics, Inc.	2013	—

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?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

The IMMULITE® Free PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of Free PSA antigen.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133816 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133816: Immulite 2000 Free Psa Calibration Verification Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133816

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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