Dirrect Agglutination(Dag) Pregnancy Test
by Sero-Immuno Diagnostics, Inc. 510(k)
Active
510(k) K852286
Overview
The Direct Agglutination (DAG) Pregnancy Test is an in vitro diagnostic device classified as an agglutination method for detecting human chorionic gonadotropin (HCG). It functions by utilizing sensitized polystyrene latex particles to identify HCG in urine or blood serum samples, producing visible agglutination as an indicator of a positive pregnancy result. This test is designed for qualitative detection of HCG, a hormone associated with pregnancy, and is categorized under the device type ‘Agglutination Method, Human Chorionic Gonadotropin’ in regulatory classifications.
This test is supplied as a single-use diagnostic reagent intended for use in clinical chemistry settings. It requires mixing with urine or serum samples to determine pregnancy status through agglutination reactions. The device is regulated under FDA 510(k) clearance (K852286) and falls under device class 2, adhering to regulatory standards for in vitro diagnostics. No information regarding sterility or MRI safety is provided, and the product is identified by the product code JHJ.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852286 | Date9 Jul 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JHJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Sero-Immuno Diagnostics, Inc.
Questions
What is the Direct Agglutination (DAG) Pregnancy Test used for?
The Direct Agglutination (DAG) Pregnancy Test is an in vitro diagnostic device designed for qualitative detection of human chorionic gonadotropin (HCG) in urine or blood serum samples. HCG is a hormone produced during pregnancy, so this test helps confirm pregnancy status by identifying its presence through a visible agglutination reaction with sensitized polystyrene latex particles.
How is the Direct Agglutination Pregnancy Test supplied and used?
The test is supplied as a single-use diagnostic reagent intended exclusively for clinical chemistry settings. To use it, the reagent is mixed with a urine or serum sample. If HCG is present, the sensitized latex particles agglutinate, producing a visible clumping that indicates a positive pregnancy result. This method relies on the agglutination reaction to provide qualitative results.
Is the Direct Agglutination Pregnancy Test sterile, and can it be reused?
The provided information does not specify whether the Direct Agglutination Pregnancy Test is sterile. However, it is explicitly labeled as a single-use diagnostic reagent, meaning it is intended for one-time use only per package. Reuse is not recommended or supported by the manufacturer’s stated specifications.
What regulatory approval does the Direct Agglutination Pregnancy Test hold?
The Direct Agglutination (DAG) Pregnancy Test holds FDA 510(k) clearance under the reference number K852286. It is classified as a Class II device and falls under the regulatory category for agglutination methods used to detect human chorionic gonadotropin (HCG). This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device.
What product code or identifier is associated with the Direct Agglutination Pregnancy Test?
The Direct Agglutination (DAG) Pregnancy Test is identified by the product code JHJ in regulatory records. This code is used for classification and tracking purposes within the FDA’s device registry and is tied to its specific regulatory submission and clearance.