510(k) · Cleared
ClearedCryocheck Weak Lupus Positive Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologic · GGC Control, Plasma, Abnormal
Cleared on Nov 3, 2003 as substantially equivalent to K952623 (Precision Biologicals, Inc., 1995) after a 55-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 3, 2003
- Review
- 55 days
- Class
- Class II
- Product code
- GGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952623 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952623 Cryo Check Lupus PlasmaPrecision Biologicals, Inc. · 1995
- This deviceK032804 Cryocheck Weak Lupus Positive ControlPrecision Biologic · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952623 | Cryo Check Lupus Plasma | Precision Biologicals, Inc. | 1995 | — |
| 0 (this device) | K032804 | Cryocheck Weak Lupus Positive Control | Precision Biologic | 2003 | — |
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 |
|---|---|---|---|
| * | K952623 | Cryo Check Lupus PlasmaSummary page 1…a, Control, Abnormal Regulatory Class II, 81 GGC Predjcate Device: CryoCheck Lupus Positive Control (K952623) Precision BioLogic Inc. 900 Wind… | 1995 |
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 K952623.
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?
CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032804 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032804: Cryocheck Weak Lupus Positive Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032804
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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