510(k) · Cleared

Cleared

Vitros Immunodiagnostic Products Range Verifiers

K973517510(k) TraditionalCleared Sep 25, 19978-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

Johnson & Johnson Clinical Diagnostics, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Sep 25, 1997 after an 8-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.

Decided: Sep 25, 1997
Review: 8 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 0

17 later devices descend from it, 8 citing it directly.

This deviceK973517 Vitros Immunodiagnostic Products Range VerifiersJohnson & Johnson Clinical Diagnostics, Inc. · 1997
Descendant · cites it directly · 4 of its ownK992349 Vitros Immunodiagnostic Products Troponin I Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
Descendant · cites it directly · 3 of its ownK990984 Vitros Immunodiagnostic Products Cea Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999
Descendant · 2 generations on · 2 of its ownK062838 Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and…Ortho-Clinical Diagnostics · 2006 · Recalled
Descendant · cites it directly · 1 of its ownK063720 Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack…Ortho-Clinical Diagnostics · 2007 · Recalled
Descendant · 2 generations on · 1 of its ownK041322 Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range…Ortho-Clinical Diagnostics, Inc. · 2004

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1998high 5 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all

K992349Vitros Immunodiagnostic Products Troponin I Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999 · cites it directly4descendants
K990984Vitros Immunodiagnostic Products Cea Range VerifiersOrtho-Clinical Diagnostics, Inc. · 1999 · cites it directly3descendants
K062838Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range Verifiers…Ortho-Clinical Diagnostics · 2006 · 2 generations on2descendants
K063720Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range VerifiersOrtho-Clinical Diagnostics · 2007 · cites it directly1descendant
K041322Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range VerifiersOrtho-Clinical Diagnostics, Inc. · 2004 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973517	Vitros Immunodiagnostic Products Range Verifiers	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—
+1	K992349	Vitros Immunodiagnostic Products Troponin I Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1999	—
+1	K990984	Vitros Immunodiagnostic Products Cea Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1999	—
+2	K062838	Vitros Troponin I ES Assay, Including Reagent Pack, Calibrators and Range…	Ortho-Clinical Diagnostics	2006	2
+1	K063720	Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators…	Ortho-Clinical Diagnostics	2007	1
+2	K041322	Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers	Ortho-Clinical Diagnostics, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	5	0
2001	1	0
2003	1	0
2004	1	0
2006	2	0
2007	1	0
2023	1	0
2024	2	0
2025	1	0

FIG. 1 — Lineage of K973517, 1997–2025Source: 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 JJY? 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?

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

What descends from it? (17)

See all 17

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K992349	Vitros Immunodiagnostic Products Troponin I Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1999	4
K990984	Vitros Immunodiagnostic Products Cea Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1999	3
K063720	Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers	Ortho-Clinical Diagnostics	2007	1
K990026	Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products…	Ortho-Clinical Diagnostics, Inc.	1999	1
K990783	Vitros Immunodiagnostic Products CA15-3 Range Verifiers, CA125 II Range Verifiers, Psa…	Ortho-Clinical Diagnostics, Inc.	1999	0
K990061	Vitros Immunodiagnostic Products Afp Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1999	0
K984011	Vitros Immunodiagnostic Products Cortisol Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1998	0
K983513	Vitros Immunodiagnostic Products Range Verifiers	Ortho-Clinical Diagnostics, Inc.	1998	0

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, K992349 (Ortho-Clinical Diagnostics, Inc., 1999) has gone furthest, with 4 descendants of its own.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of immunoassays which include TSH, Total T4. Total T3, T3 Uptake, LH, Progesterone, FSH, Total BhCG, Free T3 and Prolactin.

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/K973517 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973517: Vitros Immunodiagnostic Products Range Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973517

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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