510(k) · Cleared
Recalled · Class II · 2024Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JIS Calibrator, Primary
Cleared on Dec 22, 1999 as substantially equivalent to K970016 (Johnson & Johnson Clinical Diagnostics, Inc., 1997) after a 14-day review. Its family tree reaches back 1 generation to 1997. It has been recalled 2 times.
- Decided
- Dec 22, 1999
- Review
- 14 days
- Class
- Class II
- Product code
- JIS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970016 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK970016 Vitros Immunodiagnositcs Products-Free T3 Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997 · Recalled
- This deviceK994145 Vitros Immunodiagnostic Products Free T3 Reagent Pack, 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 | K970016 | Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3… | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | 1 |
| 0 (this device) | K994145 | Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic… | Ortho-Clinical Diagnostics, Inc. | 1999 | — |
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 JIS? 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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K970016 | Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3 Calibrators…Summary page 3…device (new formulation) are substantially equivalent to VITROS Immunodiagnostic Products Free T3 Reagent Pack for use with human serum which was cleared by the FDA (K970016) for in vitro diagnostic use. Table 1 lists the characteristics of the assays performed using the VITROS Free T3 assay (new form… | 1997 |
| * | — | VITROS Immunodiagnostic Products Free T3 Reagent Pack (original formulation) and VITROS… Named without a submission number | |
| † | K962919 | Vitros Immunodiagnostic System | 1996 |
| † | K964310 | Vitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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… |
| Apr 9, 2024 | Class II | Z-1819-2024 | Under Investigation by firm | Free T3 Calibrators used with T3 Reagent Packs 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?
- Its one ancestor has a recall.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VITROS Free T3 Reagent Pack
For in vitro diagnostic use only.
The VITROS Free T3 Reagent Pack quantitatively measures free triiodothyronine (FT3) concentration in serum and plasma (EDTA or heparin) to aid in the differential diagnosis of thyroid disease.
VITROS Free T3 Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Free T3 in serum and plasma (EDTA or heparin)
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/K994145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994145: Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994145
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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