Question 1

What types of medical devices does Tosoh Corp. manufacture?

Accepted Answer

Tosoh Corp. specializes in in vitro diagnostic (IVD) reagents and kits used primarily in clinical laboratories. Their portfolio includes liquid chromatography systems for measuring glycated haemoglobin (HbA1c), calibrators for estradiol (E2) and cancer antigen 125 (CA125), as well as controls, diluents, and enzyme immunoassay (EIA) kits for detecting biomarkers like CA125. These products support diagnostic testing for conditions such as diabetes, hormonal imbalances, and certain cancers.

Question 2

Where is Tosoh Corp. based, and how does that affect its regulatory compliance?

Accepted Answer

Tosoh Corp. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under Class I (generally low-risk) and Class II (moderate-risk) categories, requiring compliance with FDA requirements such as the 510(k) premarket notification process and Unique Device Identifier (UDI) system to ensure traceability and safety in diagnostic testing.

Question 3

Which regulatory registries or databases list Tosoh Corp.’s devices?

Accepted Answer

Tosoh Corp.’s devices are listed in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency in the regulatory process, allowing healthcare providers and authorities to verify compliance with US requirements for in vitro diagnostics. The inclusion in these systems reflects the company’s adherence to FDA-mandated standards for device classification and market clearance.

Question 4

How are Tosoh Corp.’s devices classified under FDA regulations?

Accepted Answer

Tosoh Corp.’s devices are classified under Class I (for lower-risk items like buffered solutions) and Class II (for higher-risk diagnostic tests like CA125 immunoassays and HbA1c systems). The classification depends on factors such as the device’s intended use, potential risks, and the level of regulatory oversight required. Class II devices typically require premarket notification (510(k)) to demonstrate substantial equivalence to existing approved products, while Class I devices may only need general controls unless exempt.

Device	Model / Reference	Registries	Class	Status
Aia-Pack Ck-Mb	K913298	FDA 510(k)	Class II	Active
AIA-PACK 27.29 Sample Diluting Solution	N/A	FDA UDI	Class II	Active
AIA-PACK CA 125 Calibrator Set	N/A	FDA UDI	Class II	Active
Aia-Pack Wash Concentrate	N/A	FDA UDI	N/A	Active
CL AIA-PACK hs-E2 ADJUSTER SET	N/A	FDA UDI	Class II	Active
AIA-PACK Folate	N/A	FDA UDI	Class II	Active
CL AIA-PACK hs-E2 TEST CUP	N/A	FDA UDI	Class I	Active
Aia-Pack Pa Calbrator Set	n/a	FDA UDI	Class II	Active
St Aia-Pack 27.29	N/A	FDA UDI	Class II	Active
G7 Variant Elution Buffer HSi No.1 (S)	N/A	FDA UDI	Class II	Unknown
G7 Variant Elution Buffer HSi No.3 (S)	N/A	FDA UDI	Class II	Unknown
St Aia-Pack Hcg	N/A	FDA UDI	Class II	Active
St Aia-Pack E2	N/A	FDA UDI	Class I	Active
G8 Variant Elution Buffer HSi No.3 (S)	N/A	FDA UDI	Class II	Active
AIA-PACK βHCG Calibrator Set	N/A	FDA UDI	Class II	Active
G7 Variant Elution Buffer HSi No.2 (S)	N/A	FDA UDI	Class II	Unknown
AIA-PACK CA 19-9 Calibrator Set	N/A	FDA UDI	Class II	Active
Hemoglobin F&A2 Control Set	N/A	FDA UDI	Class II	Unknown
G8 Variant Elution Buffer HSi No.1 (S)	N/A	FDA UDI	Class II	Active
St Aia-Pack Bnp	N/A	FDA UDI	Class II	Active
Aia-Pack Iri Control Set	N/A	FDA UDI	Class I	Active
Aia-Pack Prl Calibration Verification Test Set	N/A	FDA UDI	Class I	Active
ST AIA-PACK cTnI 2 Calibatator Set	N/A	FDA UDI	Class II	Active
ST AIA-PACK HbA1c	N/A	FDA UDI	Class II	Active
Aia-Pack Hcg Sample Diluting Solution	N/A	FDA UDI	Class II	Active
Aia-Pack T-U Calibrator Set	N/A	FDA UDI	Class II	Active
Aia-Pack Pap Calibration Verification Test Set	N/A	FDA UDI	Class I	Active
St-Aia-Pack Prog Ii Sample Diluting Solution	N/A	FDA UDI	Class I	Active
AIA-PACK CEA Calibration Verification Test Set	N/A	FDA UDI	Class II	Active
St Aia-Pack Prog Ii	N/A	FDA UDI	Class II	Active
AIA-PACK FT3 Calibrator Set	N/A	FDA UDI	Class II	Active
AIA-PACK AFP Calibration Verification Test Set	N/A	FDA UDI	Class I	Active
AIA-PACK 27.29 Calibrator Set	N/A	FDA UDI	Class II	Active
AIA-PACK E2 Sample Diluting Solution	N/A	FDA UDI	Class I	Active
St Aia-Pack Ca 19-9	N/A	FDA UDI	Class II	Active
St Aia-Pack Ft3	N/A	FDA UDI	Class II	Active
AIA-PACK bHCG Calibration Verification Test Set	N/A	FDA UDI	Class I	Active
Aia-Pack Hcg Calibrator Set	N/A	FDA UDI	Class II	Active
AIA-PACK FSH Calibration Verification Test Set	N/A	FDA UDI	Class I	Active
St Aia-Pack Ca 125	N/A	FDA UDI	Class II	Active
St Aia-Pack Pa	n/a	FDA UDI	Class II	Active
Aia-Pack Diluent Concentrate	N/A	FDA UDI	N/A	Active
TSKgel G8 Variant HSi	N/A	FDA UDI	Class II	Active
ST AIA-PACK cTnI 2	N/A	FDA UDI	Class II	Active
AIA-PACK FER Calibration Verification Test Set	N/A	FDA UDI	Class II	Active
ST AIA-PACK cTnI 2 Sample Dilting Solution	N/A	FDA UDI	Class II	Active
G8 Variant Elution Buffer HSi No.2 (S)	N/A	FDA UDI	Class II	Active
St Aia-Pack Prog Ii Calibrator Set	N/A	FDA UDI	Class II	Active
Aia-Pack B12	N/A	FDA UDI	Class II	Active
Aia-Pack Pa Sample Diluting Solution	n/a	FDA UDI	Class I	Active

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