510(k) · Cleared
Recalled · Class II · 2015IL Test Plasminogen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on May 26, 1998 as substantially equivalent to K864212 (Instrumentation Laboratory CO, 1986) after a 54-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.
- Decided
- May 26, 1998
- Review
- 54 days
- Class
- Class II
- Product code
- GGP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K864212 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK864212 IL Test 97573-15, Plasminogen AssayInstrumentation Laboratory CO · 1986
- This deviceK981200 IL Test PlasminogenInstrumentation Laboratory CO · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864212 | IL Test 97573-15, Plasminogen Assay | Instrumentation Laboratory CO | 1986 | — |
| 0 (this device) | K981200 | IL Test Plasminogen | Instrumentation Laboratory CO | 1998 | — |
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 GGP? 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 GGP device
- #1 K251440 CRYOcheck Chromogenic Factor VIIIscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K864212 | IL Test 97573-15, Plasminogen AssaySummary page 1…ogen Classification name(s): 864.7290 Factor Deficiency Test Class II 81GGP Test, Qualitative and Quantitative Factor Deficient Identification of predicate device(s): K864212/A IL Test™ Plasminogen . Description of the device/intended use(s): IL Test™ Plasminogen is an in vitro diagnostic test for the… | 1986 |
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 |
|---|---|---|---|---|
| Dec 18, 2015 | Class II | Z-0736-2016 | Device Design | This Lot is not meeting labeled on-board instrument stability claims of 5 days. |
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 GGP devicesGGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GGP
153in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGP
3in 2025
MAUDE reports naming product code GGP, 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 | 3 | 153 | 2 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
IL Test™ Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen in human citrated plasma based on a synthetic chromogenic substrate. Dysplasminogenemia is associated with recurrent venous thrombosis. Acquired deficiencies of Plasminogen are associated with thrombolytic therapy, sepsis and Disseminated Intravascular Coagulation.
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/K981200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981200: IL Test Plasminogen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981200
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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