NDY · Class II · 21 CFR 862.1225

FDA Product Code NDY: Test, Cystatin C

Leading manufacturers include Dade Behring, Inc., SENTINEL CH. SpA and Roche Diagnostics Corp..

22
Total
22
Cleared
126d
Avg days
2001
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 259d recently vs 120d historically

FDA 510(k) Cleared Test, Cystatin C Devices (Product Code NDY)

22 devices
1–22 of 22
Cleared May 16, 2025
Cystatin C
K242585
SENTINEL CH. SpA
Chemistry · 259d
Cleared May 25, 2018
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
K181082
Siemens Healthcare Diagnostics, Inc.
Chemistry · 31d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
K080811
Roche Diagnostics Corp.
Chemistry · 88d
Cleared Jan 22, 2007
DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH
K063351
Dade Behring, Inc.
Chemistry · 77d
Cleared Aug 16, 2004
N LATEX CYSTATIN
K041878
Dade Behring, Inc.
Chemistry · 35d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503
Dade Behring, Inc.
Chemistry · 120d

About Product Code NDY - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code NDY since 2001, with 22 receiving FDA clearance (average review time: 126 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NDY Product Code

Recent submissions under NDY have taken an average of 259 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.

NDY devices are reviewed by the Chemistry panel. Browse all Chemistry devices →