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510(k) Data Aggregation
K Number
K240865Device Name
IDS-iSYS Free Testosterone
Manufacturer
Immunodiagnostic Systems Limited
Date Cleared
2024-10-23
(209 days)
Product Code
CDZ
Regulation Number
862.1680Why did this record match?
Applicant Name (Manufacturer) :
Immunodiagnostic Systems Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries and androgenital syndromes.
Device Description
The IDS-iSYS Free Testosterone assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:
- MP3: Magnetic particles coated with Streptavidin in a phosphate Pluronic buffer with sodium azide (NaN3) as preservative (< 0.1%). 1 bottle, 2.5 mL.
- CONJ: Testosterone labelled with an acridinium ester derivative, in phosphate buffer containing bovine protein with ProClin 300 as preservative (< 0.0015%). 1 bottle, 3.5 mL
- Ab-BIOT: Monoclonal anti-Testosterone labelled with Biotin in MES buffer with ProClin 300 as preservative (<0.0015%). 1 bottle, 7.5 mL
- Cal A: Human serum matrix containing human free testosterone with sodium azide and ProClin 300 as preservatives (<0.1% and 0.0024% respectively). 1.0 mL per bottle
- Cal B: Human serum matrix containing human free testosterone with sodium azide and ProClin 300 as preservatives (<0.1% and 0.0024% respectively). 1.0 mL per bottle
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K Number
K223867Device Name
IDS ACTH II
Manufacturer
Immunodiagnostic Systems Limited
Date Cleared
2023-08-18
(238 days)
Product Code
CKG
Regulation Number
862.1025Why did this record match?
Applicant Name (Manufacturer) :
Immunodiagnostic Systems Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IDS ACTH II assay is an automated in vitro diagnostic device intended for the quantitative, determination of ACTH in human K2 and K3 EDTA plasma on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the assessment of pituitary and adrenal gland function and the differential diagnosis of hyper- and hypo-cortisolism.
Device Description
The IDS ACTH II assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:
- MP: Magnetic particles coated with mouse monoclonal anti-ACTH antibody and buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
- R1: Mouse monoclonal anti-ACTH antibody labelled with an acridinium ester derivative, in buffer containing phosphate with BSA and ProClin 300 as preservative.
- R2: Buffer containing phosphate with blocking proteins and ProClin 300 as preservative.
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