510(k) · Cleared
ClearedLA Positive Control Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Diagnostic Technologies, Inc. · GGC Control, Plasma, Abnormal
Cleared on May 24, 1996 after a 45-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- May 24, 1996
- Review
- 45 days
- Class
- Class II
- Product code
- GGC
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK961370 LA Positive Control PlasmaMedical Diagnostic Technologies, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK020109 Sigma Diagnostics Accuclot LA ControlSigma Diagnostics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK993332 Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05…Gradipore, Ltd. · 2000
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961370 | LA Positive Control Plasma | Medical Diagnostic Technologies, Inc. | 1996 | — |
| +1 | K020109 | Sigma Diagnostics Accuclot LA Control | Sigma Diagnostics, Inc. | 2002 | — |
| +1 | K993332 | Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05 | Gradipore, Ltd. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K020109 (Sigma Diagnostics, Inc., 2002) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K961370 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961370: LA Positive Control Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961370
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026