Class Class I
IDS-iSYS Free Testosterone (K240865)
Description
IDS-iSYS Free Testosterone by Immunodiagnostic Systems Limited, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK240865
Clearance Date2024-10-23
Clearance TypeTraditional
Product CodeCDZ
Regulation Number862.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240865
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. IDS-iSYS Free Testosterone (K240865) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018 |
| K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VI... | Immunodiagnostic Systems, Inc. | 2010 |
Trace the full predicate network for K240865
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.