N Latex Cystatin
by Dade Behring, Inc. 510(k)
Active
510(k) K041878
Overview
The N Latex Cystatin is an in vitro diagnostic reagent kit classified as a Test, Cystatin C (Product Code: NDY). It is designed for the quantitative measurement of cystatin C in human serum and heparinized plasma using particle-enhanced immunonephelometry on BN™ Systems. The device employs polystyrene particles coated with anti-human cystatin C antibodies to detect and quantify the analyte through aggregation in patient samples.
This device is supplied as a reagent kit for laboratory use and is intended for single-use. It is regulated under FDA 510(k) clearance (K041878) and falls under Class II – Special Controls as defined by § 862.1225. The device requires proper storage and handling in a clinical chemistry setting, adhering to standard laboratory protocols for in vitro diagnostics. No MRI safety or sterility specifications are indicated in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041878 | Date16 Aug 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NDY
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1225
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What clinical chemistry applications is the N Latex Cystatin intended for in a laboratory setting?
The N Latex Cystatin is designed specifically for the quantitative measurement of cystatin C in human serum and heparinized plasma. It uses particle-enhanced immunonephelometry on BN™ Systems to detect and quantify this biomarker, which is commonly used as an indicator of kidney function and glomerular filtration rate (GFR) assessment.
How is the N Latex Cystatin supplied, and is it meant for single-use or repeated use?
The N Latex Cystatin is supplied as a reagent kit for laboratory use. According to the data, it is intended for single-use only, meaning each kit should not be reused after opening or exposure to patient samples.
What storage and handling requirements should be followed for this diagnostic reagent?
While specific storage conditions (e.g., temperature) aren’t detailed in the provided data, the N Latex Cystatin is classified as a laboratory reagent kit for in vitro diagnostics. It must be stored and handled in compliance with standard clinical chemistry protocols to ensure accuracy and reliability of cystatin C measurements.
Does this device require any special regulatory approvals, and how was its equivalence determined?
The N Latex Cystatin holds an FDA 510(k) clearance (K041878), classified under Class II – Special Controls for § 862.1225. Its equivalence was determined through a Traditional 510(k) review by the FDA’s Clinical Chemistry (CH) Advisory Committee, with a decision dated August 16, 2004, confirming it as substantially equivalent to a predicate device.