Question 1

What types of medical devices does Immunodiagnostic Systems, Ltd. manufacture?

Accepted Answer

Immunodiagnostic Systems, Ltd. specializes in in vitro diagnostics (IVDs) for clinical chemistry and immunodiagnostic testing. Their portfolio includes automated analysers, calibrators, controls, and reagents for biomarkers like 25-hydroxy Vitamin D, bone markers (such as bone alkaline phosphatase and C-telopeptide), aldosterone, renin, and SARS-CoV-2 IgG antibodies. They also produce test tube racks and chemiluminescent immunoassay kits. These devices are designed for both laboratory and point-of-care use, with some systems supporting multi-discipline automated testing.

Question 2

Where is Immunodiagnostic Systems, Ltd. based?

Accepted Answer

The company is headquartered in the United States. While the exact location isn’t specified, their regulatory filings and device listings confirm their operational base is within the country.

Question 3

Which regulatory registries or databases list Immunodiagnostic Systems, Ltd.’s devices?

Accepted Answer

The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track devices authorised via the 510(k) pathway and ensure compliance with UDI requirements for traceability and identification.

Question 4

How are Immunodiagnostic Systems, Ltd.’s devices classified under FDA regulations?

Accepted Answer

The company’s devices fall into three classification categories under FDA regulations: Class I (generally low-risk devices requiring minimal controls), Class II (moderate-risk devices with special controls to ensure safety and effectiveness), and Not Classified (N) devices, which are exempt from classification due to their minimal risk profile. Classification depends on factors like intended use, potential risks, and regulatory history, as outlined in the FDA’s device classification database.

Question 5

What pathways are used to authorise Immunodiagnostic Systems, Ltd.’s devices?

Accepted Answer

The company’s devices are authorised through the FDA’s 510(k) premarket notification process, which demonstrates substantial equivalence to a legally marketed predicate device, and the Unique Device Identifier (UDI) system, which ensures each device has a unique, standardized identifier for tracking and regulatory compliance. These pathways are chosen based on the device’s risk level and classification.

Device	Model / Reference	Registries	Class	Status
IDS-iSYS Direct Renin	IS-4800	FDA UDI	Class II	Active
IDS-iSYS Ostase® BAP Calibration Verifiers	IS-2835US	FDA UDI	Class I	Active
IDS-iSYS Ostase® BAP	IS-2800US	FDA UDI	Class II	Active
IDS-iSYS Multi Discipline Automated System	IS-310400	FDA UDI	Class I	Active
IDS Top Cap Set	IS-CAP300	FDA UDI	Class I	Active
IDS SARS-COV-2 IgG	IS-ID6502	FDA UDI	N	Active
IDS SHBG Calibration Verifiers	IS-5635	FDA UDI	Class I	Active
1, 25 Dihydroxy Vitamin D RIA	AA-54F1	FDA UDI	Class II	Active
IDS-iSYS SDSpeed Calc	IS-SDSCALC	FDA UDI	Class I	Active
IDS-iSYS Direct Renin Control Set	IS-4830	FDA UDI	Class I	Active
IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers	IS-3035	FDA UDI	Class I	Active
IDS-iSYS 25-Hydroxy Vitamin DS Control Set	IS-2730S	FDA UDI	Class I	Active
ImCap Rack	CQ-FULL	FDA UDI	Class I	Active
IDS-iSYS 25-Hydroxy Vitamin DS	IS-2700S	FDA UDI	Class II	Active
IDS-iSYS Insulin like Growth Factor Binding Protein-3 (IGFBP-3) Cal Verifiers	IS-4435	FDA UDI	Class I	Active
25-Hydroxy Vitamin D RIA	AA-35F1	FDA UDI	Class II	Active
IDS-iSYS 25 VitDS Calibration Verifiers	IS-2535	FDA UDI	Class I	Active
IDS-iSYS Direct Renin Calibration Verifiers	IS-4835	FDA UDI	Class I	Active
ImCap Seal	CQ-Seal	FDA UDI	Class I	Active
IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers	IS-3935	FDA UDI	Class I	Active
IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers	IS-2735S	FDA UDI	Class I	Active
IDS-iSYS 17-OH Progesterone Calibration Verifiers	IS-5135	FDA UDI	Class I	Active
IDS-iSYS 17-OH Progesterone Control Set	IS-5130	FDA UDI	Class I	Active
IDS-iSYS Intact PTHN	IS-2200	FDA UDI	Class II	Unknown
IDS-iSYS Ostase® BAP Control Set	IS-2830US	FDA UDI	Class I	Active
IDS-iSYS 25 VitDS Control Set	IS-2530	FDA UDI	Class I	Active
IDS-iSYS 1, 25-Dihydroxy Vitamin D Calibration Verifiers	IS-2435	FDA UDI	Class I	Active
IDS-iSYS 25 VitDS	IS-2500	FDA UDI	Class II	Active
IDS-iSYS Aldosterone Calibration Verifiers	IS-3335	FDA UDI	Class I	Active
IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers	IS-3735	FDA UDI	Class I	Active
IDS SARS-COV-2 IgG Control Set	IS-ID6530	FDA UDI	Class I	Active
IDS-iSYS Intact PTH Calibration Verifiers	IS-3235	FDA UDI	Class I	Active
IDS-iSYS CTX-I Calibration Verifiers	K143324	FDA 510(k)	Class I	Active
Ids-Isys 25-Hydroxy Vitamin D Assay, Ids-Isys 25-Hydroxy Vitamin D Control Set	K091849	FDA 510(k)	Class II	Active
Ids-Isys Ctx-1 (crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D Calibration Verifiers, And Ids-Isys...	K111650	FDA 510(k)	Class I	Active
Ids Isys Direct Renin Assay, Ids Isys Direct Renin Control Set, And Ids Isys Direct Renin Calibration Verifiers	K123763	FDA 510(k)	Class II	Active
Ids-Isys Igf-I Calibration Verifiers	K122141	FDA 510(k)	Class I	Active
Gamma-Bct Intact Pth	K942369	FDA 510(k)	Class II	Active
Ids-Isys Ifg-I Control Set	K110412	FDA 510(k)	Class I	Active
Gamma-B 25-Hydroxy Vitamin D Ria	K991998	FDA 510(k)	Class II	Active
Octeia Igf-1 Kit	K950510	FDA 510(k)	Class I	Active
Gamma-B 1, 25-Dihydroxy Vitamin D	K042519	FDA 510(k)	Class II	Active
Octeia 25-Hydroxy Vitamin D	K021163	FDA 510(k)	Class II	Active
IDS-iSYS Intact PTHN	K161158	FDA 510(k)	Class II	Active
Ids-Isys 25-Hydroxy Vitamin Ds, And Ids-Isys 25 Hydroxy Vitamin Ds Control Set	K140554	FDA 510(k)	Class II	Active
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers	K161082	FDA 510(k)	Class I	Active

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