510(k) · Cleared
ClearedIds-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D Calibration Verifiers, and Ids-Isys...
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunodiagnostic Systems, Ltd. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Sep 6, 2011 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Sep 6, 2011
- Review
- 85 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK111650 Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25…Immunodiagnostic Systems, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK161082 IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone…Immunodiagnostic Systems, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK142994 IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS…Immunodiagnostic Systems, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK143324 IDS-iSYS CTX-I Calibration VerifiersImmunodiagnostic Systems, Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersImmunodiagnostic Systems, Ltd. · 2016 · cites it directly0descendants
- K142994IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone…Immunodiagnostic Systems, Ltd. · 2015 · cites it directly0descendants
- K143324IDS-iSYS CTX-I Calibration VerifiersImmunodiagnostic Systems, Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111650 | Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin… | Immunodiagnostic Systems, Ltd. | 2011 | — |
| +1 | K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone… | Immunodiagnostic Systems, Ltd. | 2016 | — |
| +1 | K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS… | Immunodiagnostic Systems, Ltd. | 2015 | — |
| +1 | K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
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 JJX? 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? (3)
3 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, K161082 (Immunodiagnostic Systems, Ltd., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IDS-iSYS CTX-I (CrossLaps) Control Set is intended for medical purposes for use in the IDS-iSYS CTX-I (Crosslaps) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS CTX-I (Crosslaps) Assay. The IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers are intended for use in the quantitative verification of calibration and assay range of the IDS-iSYS 25-Hydroxy Vitamin D Assay when performed on the…
Read the full statement (109 words)
The IDS-iSYS CTX-I (CrossLaps) Control Set is intended for medical purposes for use in the IDS-iSYS CTX-I (Crosslaps) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS CTX-I (Crosslaps) Assay.
The IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers are intended for use in the quantitative verification of calibration and assay range of the IDS-iSYS 25-Hydroxy Vitamin D Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
The IDS-iSYS CTX-I,(CrossLaps) Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration and assay range of the IDS-iSYS CTX-I (CrossLaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
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/K111650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111650: Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D Calibration Verifiers, and Ids-Isys....” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111650
Report an extraction error
Are you the manufacturer?
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