JMF · Radioimmunoassay, Human Placental Lactogen
Clinical Chemistry · 21 CFR 862.1585 · Class 2
Overview
| Product Code | JMF |
|---|---|
| Device Name | Radioimmunoassay, Human Placental Lactogen |
| Regulation | 21 CFR 862.1585 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A human placental lactogen test system is a device intended to measure the hormone human placental lactogen (HPL), (also known as human chorionic somatomammotrophin (HCS)), in maternal serum and maternal plasma. Measurements of human placental lactogen are used in the diagnosis and clinical management of high-risk pregnancies involving fetal distress associated with placental insufficiency. Measurements of HPL are also used in pregnancies complicated by hypertension, proteinuria, edema, post-maturity, placental insufficiency, or possible miscarriage.
Classification Rationale
Class II.
Cleared Devices (11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944933 | IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) | Diagnostic Products Corp. | Mar 10, 1995 | SESE |
| K840588 | AMERLEX HUMAN PLACENTAL LACTOGEN | Amersham Corp. | Apr 4, 1984 | SESE |
| K823292 | IMMOPHASE TM HPL RADIOIMMUNOASSAY | Corning Medical & Scientific | Dec 28, 1982 | SESE |
| K823201 | HUMAN PLACENTAL LACTOGEN KIT | Diagnostic Products Corp. | Nov 29, 1982 | SESE |
| K811370 | NATAL-TEC HPL | Armkel, LLC | May 29, 1981 | SESE |
| K802454 | GESTE FOLLOW KIT DETERM. OF HPL | Syn-Kit, Inc. | Nov 12, 1980 | SESE |
| K791854 | CENTRIA HPL RIA | Union Carbide Corp. | Oct 1, 1979 | SESE |
| K790919 | HPL RIA KIT | Technia Diagnostics , Ltd. | Jun 28, 1979 | SESE |
| K782099 | RIA TEST, NORDICALB HPL | Nordiclab Intl. | Jan 10, 1979 | SESE |
| K771656 | PROLACTIN RIA DIAG. KIT | Abbott Laboratories | Sep 22, 1977 | SESE |
| K770659 | RIALYZE HPL (RIA) | Miles Laboratories, Inc. | May 20, 1977 | SESE |
Top Applicants
- Diagnostic Products Corp. — 2 clearances
- Union Carbide Corp. — 1 clearance
- Technia Diagnostics , Ltd. — 1 clearance
- Syn-Kit, Inc. — 1 clearance
- Nordiclab Intl. — 1 clearance
