510(k) · Cleared
ClearedImmage Immunochemistry System TDM (Car,Phe,Phy, & the) Reagents
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · KLT Enzyme Immunoassay, Carbamazepine
Cleared on Feb 4, 1997 as substantially equivalent to K904226 (Abbott Laboratories, 1990) and 1 other predicate after a 144-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Feb 4, 1997
- Review
- 144 days
- Class
- Class II
- Product code
- KLT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K904226 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904226 'Tdxflx AnalyzerAbbott Laboratories · 1990
- This deviceK963673 Immage Immunochemistry System TDM (Car,Phe,Phy, & the) ReagentsBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904226 | 'Tdxflx Analyzer | Abbott Laboratories | 1990 | — |
| 0 (this device) | K963673 | Immage Immunochemistry System TDM (Car,Phe,Phy, & the) Reagents | Beckman Instruments, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 KLT? 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K980422 | TDx Carbamazepine Reagent Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…n Test System (Not Classified) Theophylline Test System (21 CFR §862.3880) Calibrator (21 CFR §862.1150) Carbamazepine (CAR) TDx®* Carbamazepine | Abbott* Laboratories, K9804226 Reagent Reagent Inc. Phenobarbital (PHE) TDx Phenobarbital Il Abbott Laboratories, K904226 Reagent Reagent Inc. Phenytoin (P… | |
| * | K904226 | 'Tdxflx AnalyzerSummary page 1…§862.1150) Carbamazepine (CAR) TDx®* Carbamazepine | Abbott* Laboratories, K9804226 Reagent Reagent Inc. Phenobarbital (PHE) TDx Phenobarbital Il Abbott Laboratories, K904226 Reagent Reagent Inc. Phenytoin (PHY) TDx Phenytoin . Reagent Reagent fi;t;bott Laboratories, K9S04226 Theophylline (THE TDx Th… | 1990 |
| Kept off the family tree | K950422 | FDA’s K950422 is First Touch Disposables Temperature Probes Our OCR of the scanned summary read K950422, FDA’s number for First Touch Disposables Temperature Probes (First Touch Disposables, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “TDx Phenytoin Reagent”. Kept off the family tree. | 1997 |
| * | K922991 | Abbott TDX/Tdxflx and Tdxflx TheophyllineSummary page 1…henytoin (PHY) TDx Phenytoin . Reagent Reagent fi;t;bott Laboratories, K9S04226 Theophylline (THE TDx Theophytline |1 Reagzz)t{ (THE) Reagent phy! Abbott Laboratories, K922991 inc. *Abbott Laboratories, Abbott Park, IL 60064 **Trademark of Abbott Laboratories Beckman Instruments, inc. twx: 910-592-126… | 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?
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K904226.
How does its category compare?
All KLT devicesKLT Enzyme Immunoassay, Carbamazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KLT
Too few KLT 510(k)s in any year since 2007 to give a median.
Recalls per year · KLT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLT
4in 2025
MAUDE reports naming product code KLT, 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 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMAGE [mmunochemistry System Carbamazepine (CAR) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of carbamazepine in human serum or plasma by rate nephelometric inhibition immunoassay. The IMMAGE Immunochemistry System Phenobarbital (PHE) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug…
Read the full statement (194 words)
The IMMAGE [mmunochemistry System Carbamazepine (CAR) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of carbamazepine in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System Phenobarbital (PHE) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenobarbital in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System Phenytoin (PHY) reagent, when used in conjunction with the Beckman IMMAGE ™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenytoin in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System Theophylline (THE) reagent when, used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of theophylline in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE™ Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, and Theophylline test 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/K963673 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963673: Immage Immunochemistry System TDM (Car,Phe,Phy, & the) Reagents.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963673
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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