510(k) · Cleared
ClearedSyscos Idc - G, Idc, BSC, Idc - G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scantibodies Laboratory, Inc. · MJX Kit, Serological, Positive Control
Cleared on Dec 24, 1997 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 24, 1997
- Review
- 41 days
- Class
- Class I
- Product code
- MJX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MJX? 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’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All MJX devicesMJX Kit, Serological, Positive Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJX
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MJX
Too few MJX 510(k)s in any year since 2007 to give a median.
Recalls per year · MJX
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJX
No MAUDE report names MJX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SYSCON IDC-G is a human serum based unassayed control used to monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens. These controls are to be used with in vitro immunoassay procedures for the qualitative determination of Chlamydia, Epstein-Barr related antigen, Borrelia burgdorferi, Herpes Complex, Hepatitis, and TORCH. These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974262 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974262: Syscos Idc - G, Idc, BSC, Idc - G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974262
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026