Abbott PAP-EIA
by Abbott Laboratories 510(k)
Active
510(k) K812925
Overview
The Abbott PAP-EIA is an Acid Phosphatase (Prostatic), Tartrate Inhibited immunoassay device, designed for quantitative measurement of prostatic acid phosphatase in serum or plasma. It employs enzyme immunoassay technology to detect and quantify this biomarker, aiding in the evaluation of prostate health and potential prostate-related conditions.
This device is supplied as a single-use reagent kit for in vitro diagnostic use in clinical chemistry laboratories. It is classified under FDA product code JFH and has received FDA 510(k) clearance (K812925) as substantially equivalent to a predicate device. Sterility and performance are validated for laboratory settings, with no MRI safety considerations noted. Storage requirements and shelf life are specified in accompanying documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812925 | Date19 Jan 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JFH
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1020
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Abbott PAP-EIA used for in clinical practice?
The Abbott PAP-EIA is an immunoassay device designed to quantitatively measure prostatic acid phosphatase (PAP) levels in serum or plasma. It uses enzyme immunoassay technology to help evaluate prostate health and assess potential prostate-related conditions, such as benign prostatic hyperplasia or prostate cancer. This aids clinicians in monitoring patients with suspected or confirmed prostate issues.
Is the Abbott PAP-EIA intended for single-use or repeated use in a laboratory?
The Abbott PAP-EIA is supplied as a single-use reagent kit, meaning each kit is designed for one-time use in in vitro diagnostic testing within clinical chemistry laboratories. This ensures consistency and sterility for accurate measurements of prostatic acid phosphatase.
What storage conditions and shelf life details are provided for the Abbott PAP-EIA?
While the exact storage conditions and shelf life are not detailed in the provided data, the accompanying documentation for the Abbott PAP-EIA specifies these requirements. It is important to follow the manufacturer’s instructions to maintain sterility and performance, as the device is validated for laboratory use only.
How is the Abbott PAP-EIA regulated by the FDA, and what does this mean for users?
The Abbott PAP-EIA has received FDA 510(k) clearance (K812925) under the product code JFH, with a decision of 'Substantially Equivalent' to a predicate device. This means it has been determined to have the same intended use and technological characteristics as a previously cleared device, ensuring it meets regulatory standards for safety and effectiveness in clinical chemistry applications.