510(k) · Cleared
Recalled · Class II · 2017Acs FRT4 Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Corning Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Jun 17, 1996 after a 59-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 17, 1996
- Review
- 59 days
- Class
- Class I
- Product code
- JJX
- Recalls
- 4
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK961510 Acs FRT4 ImmunoassayCiba Corning Diagnostics Corp. · 1996
- Descendant · cites it directly · 2 of its ownK080167 Acs 180 and Advia Centaur FT4 ImmunoassaysSiemens Healthcare Diagnostics · 2008
- Descendant · cites it directly · 1 of its ownK083373 Immulite 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK182423 Maglumi 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK160647 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK132249 Advia Centaur FT4, Advia Centaur T4Siemens Healthcare Diagnostics, Inc. · 2013
Most influential descendants
Showing 5 of 5 · See all- K080167Acs 180 and Advia Centaur FT4 ImmunoassaysSiemens Healthcare Diagnostics · 2008 · cites it directly2descendants
- K083373Immulite 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2009 · cites it directly1descendant
- K182423Maglumi 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2018 · 2 generations on0descendants
- K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on0descendants
- K132249Advia Centaur FT4, Advia Centaur T4Siemens Healthcare Diagnostics, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961510 | Acs FRT4 Immunoassay | Ciba Corning Diagnostics Corp. | 1996 | — |
| +1 | K080167 | Acs 180 and Advia Centaur FT4 Immunoassays | Siemens Healthcare Diagnostics | 2008 | — |
| +1 | K083373 | Immulite 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2009 | — |
| +2 | K182423 | Maglumi 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018 | — |
| +2 | K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +2 | K132249 | Advia Centaur FT4, Advia Centaur T4 | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | — | Ameriex-MAB FT4 Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2017 | Class II | Z-1254-2017 | Unknown/Undetermined by firm | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare… |
| Jan 10, 2017 | Class II | Z-1256-2017 | Unknown/Undetermined by firm | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare… |
| Jan 10, 2017 | Class II | Z-1255-2017 | Unknown/Undetermined by firm | Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare… |
| Jun 28, 2013 | Class III | Z-1970-2013 | Nonconforming Material/Component | Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080167 (Siemens Healthcare Diagnostics, 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 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?
For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.
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/K961510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961510: Acs FRT4 Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961510
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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