510(k) · Cleared
Recalled · 2003Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System, Coaguchek P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics/Boehringer Mannheim GmbH · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Apr 13, 1999 as substantially equivalent to K860720 (Biotrack, Inc., 1986) and 2 other predicates after a 161-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.
- Decided
- Apr 13, 1999
- Review
- 161 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K860720 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK860720 Biotrack Monitor (Biotrack Reagent Cartridges)Biotrack, Inc. · 1986
- This deviceK983892 Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System…Roche Diagnostics/Boehringer Mannheim GmbH · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860720 | Biotrack Monitor (Biotrack Reagent Cartridges) | Biotrack, Inc. | 1986 | — |
| 0 (this device) | K983892 | Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt… | Roche Diagnostics/Boehringer Mannheim GmbH | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 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 JPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K860720 | Biotrack Monitor (Biotrack Reagent Cartridges)Summary page 1…lassification name: Multipurpose system for in vitro coagulation studies We claim substantial equivalence to the Biotrack monitor and APTT test cartridges and controls, K860720, K890052, K890051. The Biotrack system is also known as the Roche Diagnostics CoaguChek Plus System, APTT test and controls. Con… | 1986 |
| * | K890052 | Biotrack Aptt Reagent CartridgeSummary page 1…tion name: Multipurpose system for in vitro coagulation studies We claim substantial equivalence to the Biotrack monitor and APTT test cartridges and controls, K860720, K890052, K890051. The Biotrack system is also known as the Roche Diagnostics CoaguChek Plus System, APTT test and controls. Continued on… | 1989 |
| * | K890051 | Biotrack Aptt ControlsSummary page 1…: Multipurpose system for in vitro coagulation studies We claim substantial equivalence to the Biotrack monitor and APTT test cartridges and controls, K860720, K890052, K890051. The Biotrack system is also known as the Roche Diagnostics CoaguChek Plus System, APTT test and controls. Continued on next pag… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 12, 2003 | Not classified | Z-0813-03 | Other | High frequency signals from other medical or communications equipment will result in a variable positive bias in test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The CoaguChek Pro APTT test is for the quantitative determination of the activated partical thromboplastin time (APTT) of freshly drawn whole blood. It is intended for health care professional use only.
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/K983892 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983892: Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System, Coaguchek P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983892
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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