RIA Test, Nordiclab HPL
510(k) K782099
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK782099 | Date10 Jan 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Ria Test, Nordicalb Hpl
- 510(k) Number
- FDA Product Code
- JMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1585
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The RIA Test, Nordiclab HPL is a radioimmunoassay test system designed to measure human placental lactogen (HPL), also known as human chorionic somatomammotrophin (HCS), in maternal serum and plasma. This diagnostic device employs radioimmunoassay technology to quantify hormone levels, aiding in clinical chemistry assessments. It falls under the classification of a Clinical Chemistry Device and is intended for laboratory use in assessing maternal hormone profiles. The test system is categorized under product code JMF and is classified as a Class II device by the FDA.
This device is supplied as a test system for in vitro diagnostic use, requiring laboratory processing. It is intended for single-use applications and must be handled according to standard radioimmunoassay protocols. The system is not sterile and is not intended for direct patient administration. Storage and handling should comply with manufacturer guidelines for radioisotope-containing materials. The device holds FDA 510(k) clearance (K782099) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent to a predicate device, as filed in 1979.
Other devices from Nordiclab Intl.
Questions
AI-generated answers, 1 Oct 2026
What is the RIA Test, Nordiclab HPL used for?
The RIA Test, Nordiclab HPL is designed to measure human placental lactogen (HPL), also called human chorionic somatomammotrophin (HCS), in maternal serum and plasma. This diagnostic tool aids clinicians in assessing maternal hormone profiles, particularly in clinical chemistry evaluations, by quantifying hormone levels using radioimmunoassay technology.
How is the RIA Test, Nordiclab HPL supplied and intended for use?
This device is supplied as a test system for in vitro diagnostic use, intended exclusively for laboratory processing. It is formulated for single-use applications only and requires adherence to standard radioimmunoassay protocols during handling. It is not sterile and is not meant for direct patient administration.
Is the RIA Test, Nordiclab HPL sterile, and can it be reused?
No, the RIA Test, Nordiclab HPL is not sterile and is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise accuracy and safety, particularly given the nature of radioimmunoassay testing.
What regulatory pathway does the RIA Test, Nordiclab HPL follow?
The RIA Test, Nordiclab HPL holds FDA 510(k) clearance under the Traditional 510(k) review pathway, with a decision dated January 10, 1979. It was determined to be substantially equivalent to a predicate device, as filed in 1978, and falls under product code JMF, classified as a Class II device.
How should the RIA Test, Nordiclab HPL be stored and handled?
Storage and handling of the RIA Test, Nordiclab HPL must comply with manufacturer guidelines for materials containing radioisotopes. This includes proper containment, shielding, and disposal procedures to ensure safety and compliance with regulatory standards for radioactive substances.