(23 days)
Not Found
No
The description details a chemical assay and a "software-resident rate math model" for calculating concentration based on reflectance changes. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
The device is for in vitro diagnostic use, meaning it's used to test samples outside of the body for diagnostic purposes, not to treat a condition directly.
Yes
The device quantitatively measures creatinine concentration in urine, and these measurements are explicitly stated to be "used in the diagnosis and treatment of renal diseases." This direct link to diagnosis and treatment classifies it as a diagnostic device.
No
The device description clearly outlines hardware components (VITROS Chemistry Products urCR DT Slides, VITROS Chemistry Products DT Calibrator Kit, VITROS DT60/DT60II Chemistry Systems) and a chemical reaction process, indicating it is not a software-only device. While software is mentioned for calibration and calculation, it is part of a larger hardware and chemical system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Measurement of Analytes: The device is designed to "quantitatively measure creatinine concentration in urine." Measuring analytes in bodily fluids is a core function of IVD devices.
- Clinical Purpose: The 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." This indicates a clinical purpose for the measurements, which is characteristic of IVDs.
- Use of Calibrators: The device description mentions the use of the "VITROS Chemistry Products DT Calibrator Kit," which is specifically formulated for calibrating the system for measuring various analytes, including urCR. Calibrators are essential components of many IVD systems to ensure accurate measurements.
- Analysis of Patient Samples: The description details how a "drop of patient sample is deposited on the slide" for analysis. IVDs analyze samples taken from the human body.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K934071) and the name "VITROS urCR assay (original device)" strongly suggests that this device is a modification or update of a previously cleared IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. VITROS urCR DT Slides quantitatively measure creatinine concentration in urine on the DT60/DT60 II analyzer.
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.
For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
JFY, JIX
Device Description
The VITROS urCR assay is performed using the VITROS Chemistry Products urCR DT Slides, and the VITROS Chemistry Products DT Calibrator Kit on VITROS DT60/DT60II Chemistry Systems.
The VITROS urCR Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a leuco dye to produce a colored product.
Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is oxidized. The resulting rate of change in reflection density is proportional to the concentration of creatinine in the sample
Once a calibration has been performed for each slide lot, creatinine concentration in unknown samples can be determined using the software-resident rate math model and the change in reflectance calculated for each unknown test slide.
VITROS DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water to which inorganic salts have been added. Once reconstituted, the appropriate standards are used to calibrate VITROS DT60/DT60 II Chemistry Systems for the quantitative measurement of creatinine in urine.
Calibration of the VITROS urCR assay requires the use of bottles 1, 2 and 4 of the VITROS DT Calibrator Kit.
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)
Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples, and human urine with measured creatinine values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS urCR assay (modified device) for use with human urine is safe and effective for the stated intended use.
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
Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a bold, sans-serif font. Below the text, there is a line, and below the line, there is the text "a Johnson & Johnson company" in a smaller font.
100 Indigo Creek Drive Rochester, New York 14626-5101
MAY 2 5 2007
510(k) Summary
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.
The assigned 510(k) number is: K071215
-
Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive MC00881 name, address, con-Rochester, New York 14626-5101 tact Phone: (585) 453-3143 FAX: (585) 453-3368 Email: mbyrne3@ocdus.jnj.com Michael M. Byrne Contact Person:
May 1. 2007 2. Preparation -
date
-
Trade or Proprietary Name: 3. Device VITROS Chemistry Products urCR DT Slides name VITROS Chemistry Products DT Calibrator Kit
VITROS urCR assay Common Name: Classification Name: Creatinine test system (21 CFR 862.1225).
VITROS DT Calibrator Kit Common Name: Classification Name: Calibrator (21 CFR 862.1150)
- The VITROS urCR assay (modified device) is substantially equivalent to the Predicate 4. VITROS urCR assay (original device). The FDA cleared the VITROS Chemdevice istry Products urCR DT Slides and VITROS Chemistry Products DT Calibrator Kit on March 21, 1994 (K934071) under the following product names:
KODAK EKTACHEM DT SLIDES (urCR) and
KODAK EKTACHEM DT Calibrator Kit
Note: With the purchase of KODAK Clinical Products Division by Johnson and Johnson, the product branding was revised to VITROS Chemistry Products urCR DT Slides and VITROS Chemistry Products DT Calibrator Kit.
Continued on next page
1
510(k) Summary, Continued
The VITROS urCR assay is performed using the VITROS Chemistry Products 5. Device deurCR DT Slides, and the VITROS Chemistry Products DT Calibrator Kit on scription VITROS DT60/DT60II Chemistry Systems.
The VITROS urCR Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a leuco dye to produce a colored product.
Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is oxidized. The resulting rate of change in reflection density is proportional to the concentration of creatinine in the sample
Once a calibration has been performed for each slide lot, creatinine concentration in unknown samples can be determined using the softwareresident rate math model and the change in reflectance calculated for each unknown test slide.
VITROS DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water to which inorganic salts have been added. Once reconstituted, the appropriate standards are used to calibrate VITROS DT60/DT60 II Chemistry Systems for the quantitative measurement of creatinine in urine.
Calibration of the VITROS urCR assay requires the use of bottles 1, 2 and 4 of the VITROS DT Calibrator Kit.
- Device intended use
For in vitro diagnostic use only.
VITROS Chemistry Products urCR DT Slides quantitatively measure creatinine concentration in urine.
For in vitro diagnostic use only.
VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
1
Continued on next page
2
510(k) Summary, Continued
- The VITROS urCR assay (modified device) is substantially equivalent 7. Comparison to the predicate, VITROS urCR assay (original), which was cleared by the to predicate FDA (K934071) for in vitro diagnostic use. device
| Device
Characteristic | Modified Device
VITROS urCR assay
(modified) | Predicate Device
VITROS urCR assay (original) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No change | For in vitro diagnostic use only.
VITROS urCR DT Slides quantitatively
measure creatinine concentration in
urine. |
| Calibration trace-
ability | The values assigned to the
VITROS Chemistry Products DT
Calibrator Kit for Creatinine are
traceable to a Gas Chromatography
Isotope Dilution Mass Spectrome-
try (GC/IDMS) method¹ and NIST
SRM®914, creatinine standard ref-
erence material. | For in vitro diagnostic use only.
VITROS Chemistry Products DT Cali-
brator Kit is specially formulated for
use as calibrators for ALB, ALKP,
ALT, AMYL, AST, TBIL, NBIL,
BUN/UREA, Ca, CHOL, CK, Cl., CO₂,
CREA, CRSC, Fe, GGT, GLU, HDLC,
K+, LAC, LDH, LIPA, Mg, Na+, NH₃,
PHOS, TP, TRIG, urCR, and URIC on
VITROS DT Chemistry Systems.
Traceable to Certified NIST (National
Institute of Standards and Technology)
Reference Material SRM® (Standard
Reference Material) 914a. |
| Reference Interval
(Urine) | Males: 1000 – 2000 mg/day²
Females: 800 – 1800 mg/day² | 800 – 2800 mg/day |
| Reportable range
Urine | 1.0 – 339.2 mg/dL*
After multiplying by a dilution factor of 21 | 2.1 – 346.5 mg/dL
*After multiplying by a dilution factor of 21 |
| Sample type | No change | Urine |
| Basic principle | No change | Colorimetric rate |
| Instrumentation | No change | VITROS DTSC/DTSCII Module |
| Table 1 List of Assay Characteristics: Comparison to Predicate Device |
|---|
Continued on next page
:
.
3
510(k) Summary, Continued
The information presented in the pre-market notification demonstrates that the 8. Conclusions The miormation probestical assay (modified device) for use with human urine is substantially equivalent to the cleared predicate device.
:
Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples, and human urine with measured creatinine values spanning the assay range.
The information presented in the premarket notification provides a reasonable assurance that the VITROS urCR assay (modified device) for use with human urine is safe and effective for the stated intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 5 2007
Ortho-Clinical Diagnostics, Inc. c/o Michael M. Byrne, RAC Regulatory Affairs Associate 100 Indigo Creek Drive Rochester, NY 14626-5101
K071215 Re:
Trade/Device Name: VITROS Chemistry Products urCR DT Slides, VITROS Chemistry Products DT Calibrator Kit Regulation Number: 21 CFR §862.1215 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY, JIX Dated: May 1, 2007 Received: May 2, 2007
Dear Mr. Byrne:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, de ricos mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (1107 that de not requently subject to the general controls provisions of the Act. The I ou may, dierelere, mains 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 n may or subject to back and 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) This letter will anow you to begin mailing of substantial equivalence of your device to a legally promation notification - Firesults 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, II you desire specific information association of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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
6
Indications for Use
| 510(k) Number (if known): | K071215 |
|---|---|
| Device Name: | VITROS Chemistry Products urCR DT Slides |
| Indications for Use: | For in vitro diagnostic use only. |
| VITROS urCR DT Slides quantitatively measure creatinine | |
| concentration in urine on the DT60/DT60 II analyzer. |
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. |
| Prescription Use | X |
| (Part 21 CFR 801 Subpart D) | AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
071215
Page 1 of 2
7
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
VITROS Chemistry Products DT Calibrator Kit
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
KD71215
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benam
Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K09/215
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