510(k) · Cleared
ClearedAcs: 180 and Advia Centaur Theophylline 2 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · KLS Enzyme Immunoassay, Theophylline
Cleared on Oct 25, 2001 as substantially equivalent to K951169 (Ciba Corning Diagnostics Corp., 1995) after a 24-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Oct 25, 2001
- Review
- 24 days
- Class
- Class II
- Product code
- KLS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951169 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951169 Ciba Corining Acs Theophylline ImmunoassayCiba Corning Diagnostics Corp. · 1995
- This deviceK013272 Acs: 180 and Advia Centaur Theophylline 2 AssayBayer Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951169 | Ciba Corining Acs Theophylline Immunoassay | Ciba Corning Diagnostics Corp. | 1995 | — |
| 0 (this device) | K013272 | Acs: 180 and Advia Centaur Theophylline 2 Assay | Bayer Corp. | 2001 | — |
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 KLS? 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 |
|---|---|---|---|
| * | K951169 | Ciba Corining Acs Theophylline ImmunoassaySummary page 1…Phone: 914-524-2446 FAX: 914-524-2500 e-mail: [email protected] ADVIA Centaur and ACS Theophylline 2 Immunoassays Theophylline immunoassay ACS Theophylline Assay K951169 Ciba Corning Diagnostics Corp 63 North Street Medfield MA 02052 Bayer ACS:180/ADVIA Centaur Theophylline 2 - Special 510(k) — D… | 1995 |
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 KLS devicesKLS Enzyme Immunoassay, Theophylline: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLS
FDA has decided no KLS device since 2007.
Median 510(k) review, days · KLS
Too few KLS 510(k)s in any year since 2007 to give a median.
Recalls per year · KLS
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLS
1in 2025
MAUDE reports naming product code KLS, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 2 | 0 |
| 2013 | 0 | — | 2 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of theophylline in human serum and plasma for use on the automated analyzer marketed by Bayer Corporation. Theophylline (1,3-dimethylxanthine) is a potent bronchodilator and respiratory stimulant that is used for the treatment of asthma. Monitoring a patient's theophylline level is very important in reducing the…
Read the full statement (133 words)
The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of theophylline in human serum and plasma for use on the automated analyzer marketed by Bayer Corporation. Theophylline (1,3-dimethylxanthine) is a potent bronchodilator and respiratory stimulant that is used for the treatment of asthma. Monitoring a patient's theophylline level is very important in reducing the risks of over- or under-medication resulting from the individual variability of theophylline absorption, metabolism and clearance and the narrow therapeutic index. The ACS and ADVIA Centaur Theophylline 2 immunoassays are used as an aid to monitor a patient's theophylline level.
The ACS and ADVIA Centaur Theophylline 2 assays are an enhanced version of the current ACS Theophylline assay. The enhancements are aimed at providing a more versatile assay in the clinical laboratory.
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/K013272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013272: Acs: 180 and Advia Centaur Theophylline 2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013272
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026