510(k) · Cleared
ClearedAce Theophylline Reagent, Theo Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiapparelli Biosystems, Inc. · KLS Enzyme Immunoassay, Theophylline
Cleared on Nov 12, 1997 as substantially equivalent to K952596 (Diagnostic Reagents, Inc., 1995) after a 51-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 12, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- KLS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952596 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952596 Theophylline Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1995
- This deviceK973583 Ace Theophylline Reagent, Theo CalibratorsSchiapparelli Biosystems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952596 | Theophylline Enzyme Immunoassay | Diagnostic Reagents, Inc. | 1995 | — |
| 0 (this device) | K973583 | Ace Theophylline Reagent, Theo Calibrators | Schiapparelli Biosystems, Inc. | 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 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 |
|---|---|---|---|
| * | K952596 | Theophylline Enzyme ImmunoassaySummary page 1…ame: Enzyme immunoassay for theophylline Classification Name: Theophylline test Predicate Device: Diagnostic Reagents, Inc. (DRI) - Theophylline Reagent [510(k) Number K952596] Device Description The ACE® Theophylline Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate… | 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?
ACE® Theophylline Reagent is intended for the quantitative determination of theophylline in serum using the ACE® clinical chemistry analyzer. Theophylline is a methylxanthine derivative which is widely used in the treatment of asthma, obstructive lung disease and neonatal apnea. The primary therapeutic effect of theophylline is due to relaxation of bronchial smooth muscle; however, theophylline has a variety of other effects. These include stimulation of…
Read the full statement (113 words)
ACE® Theophylline Reagent is intended for the quantitative determination of
theophylline in serum using the ACE® clinical chemistry analyzer.
Theophylline is a methylxanthine derivative which is widely used in the
treatment of asthma, obstructive lung disease and neonatal apnea. The primary
therapeutic effect of theophylline is due to relaxation of bronchial smooth
muscle; however, theophylline has a variety of other effects. These include
stimulation of the central nervous system and medullary respiratory centers,
decreased peripheral vascular resistance, cardiac stimulation, and diuresis. In
combination with other clinical data, monitoring serum theophylline levels
may provide the physician with useful information to aid in adjusting patient
dosage to achieve optimal therapeutic effect while avoiding drug toxicity.
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/K973583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973583: Ace Theophylline Reagent, Theo Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973583
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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