510(k) · Cleared

Recalled · Class II · 2024

Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3 Calibrators (Gem.C020)

K970016510(k) TraditionalCleared Jan 30, 199728-day reviewClass II21 CFR 862.1710Recalls 1

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. · CDP Radioimmunoassay, Total Triiodothyronine

Cleared on Jan 30, 1997 after a 28-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided: Jan 30, 1997
Review: 28 days
Class: Class II
Product code: CDP
Recalls: 1
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK970016 Vitros Immunodiagnositcs Products-Free T3 Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
Descendant · cites it directly · 0 of its ownK994145 Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros…Ortho-Clinical Diagnostics, Inc. · 1999 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K994145Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products…Ortho-Clinical Diagnostics, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970016	Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3…	Johnson & Johnson Clinical Diagnostics, Inc.	1997	—
+1	K994145	Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic…	Ortho-Clinical Diagnostics, Inc.	1999	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K970016, 1997–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K994145	Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products…	Ortho-Clinical Diagnostics, Inc.	1999	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 9, 2024	Class II	Z-1818-2024	Under Investigation by firm	T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K994145 (Ortho-Clinical Diagnostics, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CDP devices

CDP Radioimmunoassay, Total Triiodothyronine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CDP

FDA has decided no CDP device since 2007.

Median 510(k) review, days · CDP

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

Recalls per year · CDP

3in 2018

2007high 3 (2018) · low 0 (2007)2026

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

Adverse event reports per year · CDP

25in 2025

2007high 365 (2018) · low 0 (2007)2025

MAUDE reports naming product code CDP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	3
2011	—	0	8
2012	—	0	2
2013	—	2	10
2014	—	1	111
2015	—	1	158
2016	—	0	150
2017	—	1	151
2018	—	3	365
2019	—	0	343
2020	—	0	209
2021	—	0	120
2022	—	0	123
2023	—	0	131
2024	—	0	41
2025	—	0	25
2026	—	0	—

https://510kreport.com/device/K970016 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970016: Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3 Calibrators (Gem.C020).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970016

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026