LJX · Test, Urine Leukocyte
Hematology · 21 CFR 864.7675 · Class 1
Overview
| Product Code | LJX |
|---|---|
| Device Name | Test, Urine Leukocyte |
| Regulation | 21 CFR 864.7675 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | Jun 16, 2023 | SESE |
| K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | ACON Laboratories, Inc. | Oct 12, 2007 | SESE |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | Serim Research Corp. | May 5, 2000 | SESE |
| K981555 | DIASCREEN REAGENT STRIPS | Chronimed, Inc. | Jun 1, 1998 | SESE |
| K971976 | DIASCREEN REAGENT STRIPS | Dia-Screen Corp. | Jun 17, 1997 | SESE |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | Miles Laboratories, Inc. | Sep 11, 1987 | SESE |
| K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | Jan 4, 1985 | SESE |
Top Applicants
- Miles Laboratories, Inc. — 2 clearances
- ACON Laboratories, Inc. — 1 clearance
- Chronimed, Inc. — 1 clearance
- Dia-Screen Corp. — 1 clearance
- Healgen Scientific,, LLC — 1 clearance
