510(k) · Cleared
ClearedChiron Diagnostics Acs:180TU P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Diagnostics Corp. · KHQ Radioassay, Triiodothyronine Uptake
Cleared on Mar 24, 1997 as substantially equivalent to K925257 (Ciba Corning Diagnostics Corp., 1992) after a 40-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 24, 1997
- Review
- 40 days
- Class
- Class II
- Product code
- KHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925257 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK925257 Ciba Corning Acs T Uptake ImmunoassayCiba Corning Diagnostics Corp. · 1992
- This deviceK970539 Chiron Diagnostics Acs:180TU PChiron Diagnostics Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925257 | Ciba Corning Acs T Uptake Immunoassay | Ciba Corning Diagnostics Corp. | 1992 | — |
| 0 (this device) | K970539 | Chiron Diagnostics Acs:180TU P | Chiron Diagnostics Corp. | 1997 | — |
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 KHQ? 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 |
|---|---|---|---|
| * | K925257 | Ciba Corning Acs T Uptake ImmunoassaySummary page 1…62.1715" 3. Predicate Device Information Name: ACS:180 TU Assay Manufacturer: Chiron Diagnostics Corporation (Formally Ciba Corning Diagnostics Corp.) Document Control # K925257 4. Device Description The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are bound primarily to thyroxine-binding glo… | 1992 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KHQ devicesKHQ Radioassay, Triiodothyronine Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHQ
FDA has decided no KHQ device since 2007.
Median 510(k) review, days · KHQ
Too few KHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KHQ
No recall names KHQ since 2007.
Adverse event reports per year · KHQ
1in 2021
MAUDE reports naming product code KHQ, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the assessment of unsaturated thyroid binding proteins in serum or plasma using the Chiron Diagnostics ACS:180® 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/K970539 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970539: Chiron Diagnostics Acs:180TU P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970539
Report an extraction error
Are you the manufacturer?
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