Identifiers
- 510(k) Number
- K863813 FDA 510(k)
- FDA Product Code
- LGD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3780 FDA 510(k)
- Regulation Number
- 866.3780 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Toxoplasma IgG Microassay is an Enzyme Linked Immunoabsorbent Assay (ELISA) designed for the detection and semi-quantitation of human IgG antibodies to Toxoplasma gondii in human serum. It functions as an indirect immunoassay to evaluate the immunological response to Toxoplasma gondii infection, aiding in the assessment of an individual’s immune status.
This device is supplied as a single-use diagnostic test kit and is intended for use in clinical microbiology laboratories. It requires no special storage conditions beyond refrigeration and is classified under FDA product code LGD (Laboratory Reagents, General and Other). The assay received FDA 510(k) clearance (K863813) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent to the predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TOXOPLASMA IGG MICROASSAY (K863813) — FDA 510(k) | Innolitics, TOXOPLASMA IGG MICROASSAY 510 (k) K863813 - FDA.report, PDF K863813 - Toxoplasma Igg Microassay, Diamedix Corp. — FDA 510 (k) clearances & recalls · 510k Monitor, Diamedix Corp. · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K863813 | Class II | Active |
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Manufacturer
- Manufacturer
- Diamedix Corp.
Sources (1)
- FDA 510(k) K863813 24 fields · synced Sep 19, 2026