Dsl Active I-Hcg Elisa
by Diagnostic Systems Laboratories, Inc. 510(k)
Active
510(k) K961911
Overview
The DSL Active I-HCG ELISA is an in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) designed for the quantitative measurement of intact human chorionic gonadotropin (I-hCG) in human serum. It functions as a laboratory test to aid in the detection of pregnancy by detecting elevated levels of I-hCG, a hormone produced during pregnancy. This assay is categorized under visual diagnostic devices and is intended for professional laboratory use.
The DSL Active I-HCG ELISA is supplied as a single-use reagent kit and requires laboratory processing. It is not intended for reusable applications and is regulated under FDA 510(k) clearance (K961911) as a Class II device, with a decision date of June 28, 1996. The assay is intended for use in clinical chemistry settings and adheres to regulatory standards outlined in 21 CFR 862.1155. No specific MRI safety or sterility classifications are noted in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961911 | Date28 Jun 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
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Questions
What is the primary clinical use of the DSL Active I-HCG ELISA kit in a laboratory setting?
The DSL Active I-HCG ELISA is designed for the quantitative measurement of intact human chorionic gonadotropin (I-hCG) in human serum. It aids in detecting pregnancy by identifying elevated levels of I-hCG, a hormone produced during pregnancy, and is intended for professional laboratory use in clinical chemistry settings.
Is the DSL Active I-HCG ELISA kit reusable, or is it meant for single-use only?
The DSL Active I-HCG ELISA is explicitly supplied as a single-use reagent kit. It is not intended for reusable applications, requiring laboratory processing for each test.
How is the regulatory status of this device determined, and what does that mean for its use?
The DSL Active I-HCG ELISA is regulated under an FDA 510(k) clearance (K961911) and is classified as a Class II device. This means it has been determined to be substantially equivalent to a legally marketed device and is authorized for use in clinical chemistry settings as outlined in 21 CFR 862.1155. The clearance was granted by the FDA’s Clinical Chemistry (CH) advisory committee in 1996.
What type of laboratory environment is this test intended for, and does it require any special handling?
The DSL Active I-HCG ELISA is intended for professional laboratory use in clinical chemistry settings. While the data does not specify sterility classifications, it is a single-use reagent kit requiring standard laboratory processing. No special handling beyond typical ELISA assay procedures is mentioned in the provided details.
Are there multiple versions or sizes of this test kit, or is it available in a single configuration?
The provided data lists multiple FEI numbers, which may correspond to different lot or batch configurations, but it does not specify distinct sizes, models, or versions of the DSL Active I-HCG ELISA kit. The device is primarily described as a single-use reagent kit without additional variations mentioned.