LA-Histo Antibody System #HL 1001
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K830837 FDA 510(k)
- FDA Product Code
- GMJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3320 FDA 510(k)
- Regulation Number
- 866.3320 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LA-Histo Antibody System #HL 1001 is an Antigens, Histoplasma Capsulatum device, classified under FDA product code GMJ. It consists of antigens and antisera designed for serological testing to detect antibodies to Histoplasma capsulatum in serum samples. This system aids in the microbiological identification of histoplasmosis infections by facilitating antibody detection through standardized immunoassays. The device is intended for use in laboratory settings where serological analysis is required for diagnostic purposes.
This system is supplied as a Class 2 medical device and was cleared under FDA 510(k) number K830837 with a decision of Substantially Equivalent in 1983. It is intended for single-use in clinical microbiology laboratories, adhering to regulatory standards for serological reagents. Storage and handling conditions are not specified in the regulatory data but must comply with standard laboratory protocols for antigen-antibody test kits. The device is authorized for use in the United States under the specified clearance.
Frequently asked questions
What is the LA-Histo Antibody System #HL 1001 used for?
The LA-Histo Antibody System #HL 1001 is designed for serological testing to detect antibodies against *Histoplasma capsulatum* in serum samples. This helps microbiology laboratories confirm histoplasmosis infections by identifying immune responses through immunoassay methods. It is specifically intended for use in laboratory settings where precise antibody detection is required for diagnostic purposes.
How is the LA-Histo Antibody System #HL 1001 supplied and intended for use?
The system is supplied as a Class 2 medical device and is intended for single-use in clinical microbiology laboratories. It includes antigens and antisera preconfigured for standardized immunoassays. Since it is not reusable, each kit must be used once per test procedure, adhering to standard laboratory protocols for serological reagents. Storage conditions are not specified in regulatory data but should follow general guidelines for antigen-antibody test kits to maintain integrity.
Is regulatory approval for the LA-Histo Antibody System #HL 1001 available in the U.S.?
Yes, the device was cleared by the FDA under 510(k) number K830837 in 1983 as Substantially Equivalent to a predicate product. This clearance authorizes its use in the United States for the specified diagnostic purpose. The decision was made by the Microbiology Advisory Committee (MI) under the Traditional 510(k) review pathway, ensuring compliance with regulatory standards for serological reagents.
What are the key specifications or limitations of the LA-Histo Antibody System #HL 1001?
The system is classified under FDA product code GMJ and falls under the Microbiology medical specialty. While no explicit storage instructions are provided in the regulatory data, it must comply with standard laboratory protocols for antigen-antibody test kits. The device is single-use only, and its design focuses on facilitating antibody detection in serum samples for histoplasmosis diagnosis. No additional specifications (e.g., sizes, models) are detailed beyond the model number #HL 1001.
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: LA-HISTO ANTIBODY SYSTEM #HL 1001 (K830837) - Innolitics, La-histo Antibody System #Hl 1001 - Fda K830837, La-histo Antibody System #Hl 1001 - Beudamed, HL1001 | LA-Histoplasma Antibody System Clinisciences
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K830837 | Class II | Active |
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Manufacturer
- Manufacturer
- Immuno-Mycologics, Inc.
Sources (1)
- FDA 510(k) K830837 24 fields · synced Oct 1, 2026