(71 days)
Not Found
No
The device description details a standard immunoassay method based on latex agglutination and turbidity measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is for in vitro diagnostic use, meaning it measures substances in bodily fluids to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurement of Cystatin C aids in the diagnosis and treatment of renal disease," indicating its role in diagnosis. It also mentions "For in vitro diagnostic use."
No
The device description clearly states it is a "suspension of uniform latex particles coated with anticystatin-C antibody" and involves "agglutination," indicating a physical reagent and a chemical reaction, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "For in vitro diagnostic use" for both the reagent and the calibrator. It also describes the purpose of the test (quantitative determination of Cystatin-C in human serum or plasma) and how it aids in the diagnosis and treatment of renal disease.
- Device Description: Describes a test performed on biological samples (serum or plasma) outside of the body, which is the definition of an in vitro diagnostic test. The mechanism of action (agglutination of latex particles) is also consistent with an in vitro assay.
N/A
Intended Use / Indications for Use
Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin C (CYSC) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease.
Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.
Product codes (comma separated list FDA assigned to the subject device)
NDY, JIT
Device Description
The CYSC latex reagent is a suspension of uniform latex particles coated with anticystatin-C antibody. When serum or plasma containing cystatin C is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 and 805 nm. The cystatin C concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness for the
ADVIA® Chemistry Cystatin C Method
MAR 1 1 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number:
B. Date of Preparation: December 22, 2008
C. Proprietary and Established Names:
ADVIA® Chemistry Cystatin C Reagent ADVIA® Chemistry Cystatin C Calibrator
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Kira Gordon, Sr. Regulatory Affairs Specialist
Office: (914) 524-2996 Fax: (914) 524-2500
E. Regulatory Information:
ADVIA Chemistry Cystatin C Reagent
-
- Regulation section: 21 CFR § 862.1225 Creatinine, test system.
-
- Classification: Class II
-
- Product Code: NDY, Test, Cystatin C
-
- Panel: Clinical Chemistry
ADVIA Chemistry Cystatin C Calibrator
-
- Regulation section: 21 CFR § 862.1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIT, calibrator secondary
-
- Panel: Clinical Chemistry
1
F. Predicate Device:
ADVIA Chemistry Cystatin C reagent is substantially equivalent to the Dade Behring N Latex Cystatin C reagent cleared under K041878
ADVIA Chemistry Cystatin C calibrator is substantially equivalent to the Dade Behring N Protein Standard UY cleared under K003501.
G. Device Description:
The CYSC latex reagent is a suspension of uniform latex particles coated with anticystatin-C antibody. When serum or plasma containing cystatin C is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 and 805 nm. The cystatin C concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.
H. Intended Use:
Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin C (CYSC) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease.
Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.
I. Substantial Equivalence Information:
The ADVIA Chemistry Cystatin C Method and (formerly) Dade Behring, Inc., N Latex Cystatin C methods were compared. A comparison of the important similarities and differences between the devices and the predicates is provided in the following tables:
| .
LA CAR SHEAR
similarities | A B = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
.
A REAL PRODUCT CONNUMBER | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 - 4 -
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| .
called in the same may was | And Concession of Canadian Company of Children
14-14-11-14
a
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · |
1 12 65 5
11/2/11
Property
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| A 46-44-4844
na Vit | 44-4-4-448-1-800-
. | Company Control Concession Company of Children
. |
2
| Intended Use | Reagent: for in vitro diagnostic
use in the quantitative
determination of cystatin C in
human serum and plasma on the
ADVIA Chemistry
systems.Measurement of cystatin
C aids in the diagnosis and
treatment of renal diseases.
Calibrator: For in vitro diagnostic
use in the calibration of the
Cystatin C method on ADVIA
Chemistry systems. | Reagent: N Latex CYSC method is
an in vitro diagnostic kit for the
quantitative determination of
cystatin C in human serum and
heparinized plasma. Cystatin C
measurements are used in the
diagnosis and treatment of renal
diseases.
Calibrator: For preparing reference
curves for the
immunonephelometric
determinations of a-1-micorglobulin
and Cystatin C using the BN
systems. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Antibody | Rabbit Polyclonal antibodies to
human Cystatin C | Rabbit Polyclonal antibodies to
human Cystatin C |
| Format | Liquid | Liquid |
| Use of
Calibrators | Yes | Yes |
| Traceability | internal standard of highly purified
human cystatin C | internal standard of highly purified
human cystatin C |
| Reference
range | 0.56-0.95 mg/L | 0.53 -0.95 mg/L |
| Differences | | |
| Item | Device | Predicate |
| Sample
Matrix | Serum , Heparinized Plasma,
EDTA plasma | Serum or Heparinized Plasma |
| Reagents | Two: R1 (buffer), R2 (latex coated
with anti-cystatin C antibody from
rabbit) contained in system
specific packaging | Three: (1) latex coated with anti-
cystatin C antibody from rabbit, (2)
Supplementary A (rabbit antibody),
(3) Supplementary B (polyethylene
glycol) in system specific packaging |
| Technology /
Methodology | Latex enhanced
turbidimetric assay | Particle enhanced
immunonephelometric assay |
| Number of
Calibrators | 6 (5 provided in package and
zero-calibrator - DI water) | 1 (diluted on system to 6 levels) |
| Calibrators | Recombinant Cystatin C in human
serum base (liquid) | Urinary proteins of human origin
polygeline and preservatives
(lyophilized) |
| Reportable
range | 0.1 - 8.0 mg/L | 0.05 - 8.0 mg/L |
and the state of the states and
:
3
J. Conclusion:
The ADVIA Chcmistry Cystatin C Method is substantially equivalent to the A Dade Behring, Inc., N Latex Cystatin C method cleared under K041878. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
4
Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the edge. In the center of the seal is an abstract image of an eagle.
MAR 1 1 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics c/o Dr. Kira Gordon 511 Benedict Avenue Tarrytown, New York 10591
Re: K083906 Trade/Device Name: ADVIA Chemistry Cystatin C Reagent Regulation Number: 21CFR 862.1225 Regulation Name: Creatinine, test system Regulatory Class: Class II Product Code: NDY, JIT Dated: December 23, 2008 Received: December 30, 2008
Dear Dr. Gordon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page - 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Corg C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
6
Indication for Use
510(k) Number (if known): K083906
Device Name:
ADVIA® Chemistry Cystatin C Reagent
ADVIA® Chemistry Cystatin C Calibrator
Indication For Use:
Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin-C (CYSC) in human serum or plasma (lithium heparin, potassium EDTA) on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease.
Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.
Prescription Use
(21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Rute Chealer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 083906