510(k) · Cleared
ClearedGradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gradipore, Ltd. · GGC Control, Plasma, Abnormal
Cleared on Feb 16, 2000 as substantially equivalent to K961370 (Medical Diagnostic Technologies, Inc., 1996) after a 135-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Feb 16, 2000
- Review
- 135 days
- Class
- Class II
- Product code
- GGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961370 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK961370 LA Positive Control PlasmaMedical Diagnostic Technologies, Inc. · 1996
- This deviceK993332 Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05…Gradipore, Ltd. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961370 | LA Positive Control Plasma | Medical Diagnostic Technologies, Inc. | 1996 | — |
| 0 (this device) | K993332 | Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05 | Gradipore, Ltd. | 2000 | — |
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 GGC? 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 |
|---|---|---|---|
| * | K961370 | LA Positive Control PlasmaSummary page 1…ary 17, 2000 GradiPlasma LA High and Low Lupus Anticoagulant Quality Control Plasmas Control, Plasma, Abnormal Per 21CFR section 864.7925, Class II Verify® LA Control, K961370 Description of the device / intended use: GradiPlasma LA High and Low are preparations of fresh human citrated plasma with adde… | 1996 |
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.
- 1 other device also cites its predicate K961370.
How does its category compare?
All GGC devicesGGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGC
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · GGC
Too few GGC 510(k)s in any year since 2007 to give a median.
Recalls per year · GGC
No recall names GGC since 2007.
Adverse event reports per year · GGC
1in 2021
MAUDE reports naming product code GGC, 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 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 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 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
GradiPlasma LA High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore.
GradiPlasma LA Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays, specifically LA SCREEN (DRVVT) and LA CONFIRM (DRVVT) from Gradipore.
Validation studies for the GradiPlasma LA High and GradiPlasma LA Low have been performed using IL ACL300, IL MLA 800 and Dade Behring BCT instruments.
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/K993332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993332: Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993332
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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