510(k) · Cleared
ClearedArchitect I Theophylline Reagents and Calibrators (a-F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biokit, S.A. · LGS Fluorescence Polarization Immunoassay, Theophylline
Cleared on Jun 8, 2007 as substantially equivalent to K953016 (Abbott Laboratories, 1995) after a 74-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 8, 2007
- Review
- 74 days
- Class
- Class II
- Product code
- LGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953016 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953016 Axsym Theophylline IIAbbott Laboratories · 1995
- This deviceK070810 Architect I Theophylline Reagents and Calibrators (a-F)Biokit, S.A. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953016 | Axsym Theophylline II | Abbott Laboratories | 1995 | — |
| 0 (this device) | K070810 | Architect I Theophylline Reagents and Calibrators (a-F) | Biokit, S.A. | 2007 | — |
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 LGS? 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 |
|---|---|---|---|
| * | K953016 | Axsym Theophylline IISummary page 2…f 3 510(K) Submission 510 (K)Summary Legally marketed device to which equivalency is claimed: AxSYM Theophylline II (K953016) Intended Use of Device: The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) fo… | 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 LGS devicesLGS Fluorescence Polarization Immunoassay, Theophylline: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LGS
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · LGS
Too few LGS 510(k)s in any year since 2007 to give a median.
Recalls per year · LGS
No recall names LGS since 2007.
Adverse event reports per year · LGS
2in 2010
MAUDE reports naming product code LGS, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or…
Read the full statement (105 words)
The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy.
The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum or plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070810 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070810: Architect I Theophylline Reagents and Calibrators (a-F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070810
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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