Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30
510(k) K974859
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974859 | Date22 Jan 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CFJ
- FDA applicant
- Diagnostic Chemicals , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1440
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lactate Dehydrogenase-SL Assay is an in vitro diagnostic device used for measuring lactate dehydrogenase (LDH) activity in serum or plasma samples. LDH is an enzyme found in many tissues, and its levels are clinically significant in diagnosing and monitoring conditions such as tissue damage, myocardial infarction, hemolytic anemia, and liver disease. This assay quantifies LDH activity through a spectrophotometric method, enabling precise clinical assessment.
The assay is supplied as a reagent kit for use in clinical chemistry laboratories, requiring manual preparation and analysis. It is intended for single-use and is not sterile, as it is designed for reagent preparation in a controlled laboratory environment. The assay is available in two sizes: R1 (3 x 100 mL) and R2 (1 x 75 mL). Regulatory clearance under the FDA’s 510(k) pathway (K974859) confirms its compliance with Class II device standards for clinical chemistry applications, with no third-party certification indicated.
Other devices from Diagnostic Chemicals, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What clinical conditions is the Lactane Dehydrogenase-SL Assay used to diagnose or monitor?
The Lactane Dehydrogenase-SL Assay measures lactate dehydrogenase (LDH) activity, an enzyme found in many tissues. Elevated LDH levels are clinically significant for diagnosing and monitoring tissue damage, myocardial infarction, hemolytic anemia, and liver disease. By quantifying LDH activity through spectrophotometry, clinicians can assess these conditions with greater precision.
How is the Lactane Dehydrogenase-SL Assay supplied, and what sizes are available?
The assay is supplied as a reagent kit designed for manual preparation and analysis in clinical chemistry laboratories. It is available in two sizes: R1 (3 x 100 mL) and R2 (1 x 75 mL). The kit includes all necessary reagents for performing the test, but it requires laboratory setup and handling.
Is the Lactane Dehydrogenase-SL Assay sterile, and is it intended for single-use?
The Lactane Dehydrogenase-SL Assay is not sterile, as it is intended for reagent preparation in a controlled laboratory environment. It is explicitly designed for single-use only, meaning each kit should not be reused after opening or preparation.
What regulatory pathway does the Lactane Dehydrogenase-SL Assay follow?
The assay has received FDA clearance under the 510(k) pathway (K974859), confirming compliance with Class II device standards for clinical chemistry applications. This clearance was granted by the FDA’s Center for Devices and Radiological Health, ensuring its safety and effectiveness for measuring LDH activity in serum or plasma samples.
Can this assay be used with both serum and plasma samples?
Yes, the Lactane Dehydrogenase-SL Assay is specifically designed for measuring LDH activity in both serum and plasma samples. This versatility allows clinicians to use the assay across a broader range of diagnostic scenarios, depending on the sample type available for testing.