(35 days)
Not Found
No
The description details a standard immunonephelometry assay based on light scattering and comparison to a known standard, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) kit used for quantitative determination of cystatin C to aid in the diagnosis and treatment of renal diseases. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the kit is an "in vitro diagnostics kit" and that "Cystatin C measurements are used in the diagnosis and treatment of renal diseases."
No
The device is an in vitro diagnostic kit containing reagents and polystyrene particles, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BN™ Systems."
This statement clearly identifies the device as an in vitro diagnostic kit.
N/A
Intended Use / Indications for Use
N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BN™ Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.
Product codes
NDY
Device Description
Polystyrene particles coated with specific antibodies to human cystatin C are aggregated when mixed with samples containing human cystatin C. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 1 6 2004
510(k) Summary for N Latex Cystatin C
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.
Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number K041878 written in handwriting. The number is written in black ink and is underlined. The text and number are likely part of a document or form related to a 510(k) submission.
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1.
Manufacturer:
Preparation:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781.826.4551
Preparation date:
July 9, 2004
Device Name/ Classification: 2.
Device Name: Device Description: Classification: Regulation Number: Panel: Product Code:
N Latex Cystatin C Creatinine test system Class II 21 CFR 862.1225 Clinical Chemistry NDY
Identification of the Legally Marketed Device: 3.
N Latex Cystatin C - K003503
Device Description: 4.
Polystyrene particles coated with specific antibodies to human cystatin C are aggregated when mixed with samples containing human cystatin C. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.
1
Device Intended Use: 5.
N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative N Latex Oyotatin O io an in W.P allag recum and heparinized plasma by means of particleenhanced immunonephelometry using BN™ Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.
Medical device to which equivalence is claimed and comparison information: 6.
The modified N Latex Cystatin C assay is substantially equivalent in intended use to the currently marketed N Latex Cystatin C assay (K003503).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human profiles or abstract shapes, possibly representing the department's focus on people and services. The logo is black and white.
AUG 1 6 2004
000 and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Site PO Box 6101 Newark, DE 19714
K041878 Re: Trade/Device Name: N Latex Cystatin C Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: NDY Dated: July 9, 2004 Received: July 15, 2004
Dear Ms. Dray-Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent date of the Medical Device Amendments, or to conninered prof to they 2017-11-11 in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetter For (110) that be device, subject to the general controls provisions of the Act. The r ou may, mercrere, mains of the Act include requirements for annual registration, listing of general controls provisions 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 it may be subject to Sach adde 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 r lease of actived had i brinnation that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I ederal statutes and securities, 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).
3
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,
Seain M. Cooper MS, DVM.
Jean M. Cooper MS DVM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications Statement
Device Name: N Latex Cystatin C
Indications for Use:
N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BN™ Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.
Prescription Use
(Per 21 CFR 801.109)
✓
Over-The-Counter-Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol Benson
Division Sign-Off
Office of in Vitro Dlag
510(k) K041878
000033