Ld-1
by Abbott Laboratories 510(k)
Active
510(k) K981338
Overview
The LD-1 is a Differential Rate Kinetic Method for quantifying Lactate Dehydrogenase (LD) isoenzymes in human serum, specifically isolating LD-1 activity. It employs a proprietary reagent system incorporating a chaotropic agent—such as sodium perchlorate—to selectively stabilize LD-1 while inactivating other isoenzymes, enabling precise differentiation and measurement.
This in vitro diagnostic device is supplied as a reagent kit for laboratory use under controlled conditions. It is intended for single-use and requires no sterilization beyond manufacturer-provided packaging. The device operates within Class II regulatory classification (Special Controls) under FDA 510(k) clearance (K981338) and is authorized for clinical chemistry applications. Storage and handling must adhere to the manufacturer’s instructions to maintain reagent integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981338 | Date18 May 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JGF
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1445
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the LD-1 device used for?
The LD-1 is an in vitro diagnostic reagent kit designed to quantify Lactate Dehydrogenase (LD) isoenzymes in human serum by specifically isolating and measuring LD-1 activity using a proprietary reagent system that includes a chaotropic agent to stabilize LD-1 while inactivating other isoenzymes.
How is the LD-1 supplied and is it intended for single use or reuse?
The LD-1 is supplied as a reagent kit for laboratory use and is intended for single-use only; it requires no additional sterilization beyond the manufacturer’s provided packaging to maintain reagent integrity and performance.
What regulatory pathway was used for the LD-1 device and what is its classification?
The LD-1 received FDA 510(k) clearance under submission K981338 and is classified as a Class II medical device subject to Special Controls, as indicated by its regulatory pathway and device classification in the authorization data.
What storage conditions are required for the LD-1 reagent kit?
The LD-1 reagent kit must be stored and handled according to the manufacturer’s instructions to maintain reagent integrity, as specified in the device data, though specific temperature or environmental conditions are not detailed in the provided information.
What type of methodology does the LD-1 employ to measure LD-1 isoenzyme activity?
The LD-1 uses a Differential Rate Kinetic Method that incorporates a proprietary reagent system with a chaotropic agent, such as sodium perchlorate, to selectively stabilize LD-1 and inactivate other lactate dehydrogenase isoenzymes for precise differentiation and measurement in human serum.