(173 days)
Not Found
No
The description focuses on enzymatic measurement and signal analysis for error detection, with no mention of AI or ML techniques.
No
This device is for in vitro diagnostic use, meaning it analyzes samples outside of the body to aid in diagnosis and treatment monitoring, rather than directly treating a condition.
Yes.
The "Intended Use" clearly states that the device is "for in vitro diagnostic use" and that "The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases".
No
The device description clearly describes a physical cartridge with sensors and a system for analyzing whole blood, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use."
- Nature of the Test: The device measures creatinine in human whole blood, which is a biological sample taken from the body.
- Purpose of the Measurement: The measurement of creatinine is used to "aid in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis." This is a diagnostic purpose.
- Device Description: The description details a "single use, disposable cartridge, for the in vitro measurement of creatinine in whole blood."
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis.
Product codes
JFY
Device Description
The IRMA® SL Blood Analysis System CR Creatinine Cartridge is for use with the IRMA Blood Analysis System. The creatinine cartridge is a single use, disposable cartridge, for the in vitro measurement of creatinine in whole blood.
Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The creatinine sensor uses an enzymatic method for measuring creatinine. The IRMA sensors are calibrated prior to each test using a calibrant packaged with the sensor. Calibration of the cartridge is completed when information determined at the factory for each lot of cartidges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.
Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.
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
professional use
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)
Accuracy:
Analyte: Creatinine
Range evaluated: 0.5 - 10.1 mg/dl
Slope: 0.94
Intercept: 0.16
Sy.x: 0.55
Precision:
Level 1: N=12, IRMA Creatinine Mean (mg/dl)=0.67, IRMA Creatinine Total Precision sd=0.085, IRMA Creatinine Total Precision %CV=12.6
Level 2: N=56, IRMA Creatinine Mean (mg/dl)=1.93, IRMA Creatinine Total Precision sd=0.073, IRMA Creatinine Total Precision %CV=3.8
Level 3: N=54, IRMA Creatinine Mean (mg/dl)=4.41, IRMA Creatinine Total Precision sd=0.399, IRMA Creatinine Total Precision %CV=9.1
Level 4: N=58, IRMA Creatinine Mean (mg/dl)=10.17, IRMA Creatinine Total Precision sd=0.704, IRMA Creatinine Total Precision %CV=6.9
Level 5: N=60, IRMA Creatinine Mean (mg/dl)=17.80, IRMA Creatinine Total Precision sd=1.366, IRMA Creatinine Total Precision %CV=7.7
Level 6: N=52, IRMA Creatinine Mean (mg/dl)=22.68, IRMA Creatinine Total Precision sd=1.654, IRMA Creatinine Total Precision %CV=7.3
Linearity:
Analyte: Creatinine
Display Range: 0.2 – 20.0 mg/dl
Assessment: Linear
The data demonstrates that the Creatinine Cartridge is as safe, effective and performs as well as the legally marketed predicate device to which equivalence is claimed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope, Intercept, Sy.x, Mean, Standard Deviation, %CV
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
Image /page/0/Picture/0 description: The image shows the logo for Diametrics Medical. The logo consists of a stylized "D" shape on the left, followed by the words "DIAMETRICS" and "MEDICAL" stacked on top of each other. The "D" shape is black and white and has a few circles and lines inside of it.
JUN 2 5 2003
Fax: 651/639.8549 55113-1136 USA Phone: 651/639.8035 Saint Paul MN 2658 Patton Road
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92.
1030035 The assigned 510(k) number is: _
Submitter:
Diametrics Medical, Inc. 2658 Patton Rd Roseville, MN 55113 Phone: (651) 638-1250 Fax: (651) 638-1060 Contact Person: Nancy Ring
Establishment Registration Number:
Summary Prepared on:
Identification of Device:
Device Name: Proprietary Name: Cartridge Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Name of Predicate Device:
| Predicate Device 510(k) Number: | K875191 |
|---|---|
| Predicate Device Product Code: | 75 JFY |
Substantial Equivalence Claim
The IRMA® SL Blood Analysis System GL Cartridge is substantially equivalent in method, intended use and clinical performance to the currently marketed Vitros DT60 H Chemistry System / Vitros CRSC DT Slides.
2183953
January 2, 2003
Creatinine Cartridge IRMA® SL Blood Analysis System CR
Creatinine Test System Enzymatic method, creatinine Class II 21 CFR 862.1225 Chemistry (75) ורצ
Vitros DT60 II Chemistry System / Vitros CRSC DT Slides
1
Device Description
The IRMA® SL Blood Analysis System CR Creatinine Cartridge is for use with the IRMA Blood Analysis System. The creatinine cartridge is a single use, disposable cartridge, for the in vitro measurement of creatinine in whole blood.
Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The creatinine sensor uses an enzymatic method for measuring creatinine. The IRMA sensors are calibrated prior to each test using a calibrant packaged with the sensor. Calibration of the cartridge is completed when information determined at the factory for each lot of cartidges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.
Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.
Intended Use
The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
Indications for Use
The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis.
2
Summary of Technological Characteristics
The following table shows comparison to the predicate device.
| IRMA® | Vitros DT60 II | |
|---|---|---|
| Detection Method | Creatinine Oxidase | Creatinine amidohydrolase / |
| creatinine amidinohydrolase / | ||
| sarcosine oxidase | ||
| Measuring Range | Creatinine: 0.2 - 20.0 | |
| mg/dL (17.7 - 1768.5 | ||
| mmol/L) | Creatinine: 0.05 - 16.5 mg/dL | |
| (4 - 1459 mmol/L) | ||
| Minimum Detection | ||
| Limit | Creatinine: 0.04 mg/dl | |
| (3.5 mmol/L) | Not Specified | |
| Operating Temp. | 12-30°C (59-86°F) | 15.5-35°C (60-85°F) |
| Operating Humidity | 0-80% | 15-75% |
| Sample | Whole blood | Serum or plasma |
| 0.2 - 3.0 mL, from syringe | ||
| 0.125 mL from capillary | ||
| collection device | 10 µL | |
| Power | 7.2 V NiCAD rechargeable | |
| battery or AC adapter | 120 VAC | |
| 240 VAC | ||
| Reagents | Supplied in self-contained | |
| disposable cartridge | Supplied in a dry multi-layered | |
| film within a disposable plastic | ||
| support | ||
| Weight | 5 lbs. | 19 lbs. |
| Results | Display and printer on | |
| board | Display and printer on board | |
| Calibration | Automatic with each | |
| sample | Manual calibration with each new | |
| lot of Vitros DT slides, or when | ||
| QC results using Vitros DT | ||
| Controls are out of range |
3
Summary of Performance Data:
Accuracy:
| curacy: | ||||||
|---|---|---|---|---|---|---|
| Analyte | 1 | Range evaluated | Slope | Intercept | Sy.x | |
| A market of the comments of the country of the county of | ||||||
| Company of Children | ||||||
| Creatinine | ||||||
| The later the many of the many of the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of | 10 | 0.5 - 10.1 mg/dl | 0.94 | 0.16 | 0.98 | 0.55 |
Precision:
| Level | N | IRMA
Creatinine
Mean (mg/dl) | IRMA
Creatinine Total
Precision sd | IRMA Creatinine
Total Precision
%CV |
|-------|----|------------------------------------|------------------------------------------|-------------------------------------------|
| 1 | 12 | 0.67 | 0.085 | 12.6 |
| 2 | 56 | 1.93 | 0.073 | 3.8 |
| 3 | 54 | 4.41 | 0.399 | 9.1 |
| 4 | 58 | 10.17 | 0.704 | 6.9 |
| 5 | 60 | 17.80 | 1.366 | 7.7 |
| 6 | 52 | 22.68 | 1.654 | 7.3 |
Linearity:
| Analyte | | Display Range
and the state the station and the first and the first of the first of the first and | Assessment |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Creatinine
Comments of the controlled on the controlled on the controlled of the controlled of the controlled of the contribution of the contribution of the contribution of the contribu | 20 | 0.2 – 20.0 mg/dl | Linear
The first and the many of the many of the many of the many of the many of the may be any the may be any the comments of the may be the comments of the comments of the comment |
Conclusions:
The data demonstrates that the Creatinine Cartridge is as safe, effective and performs as well as the legally marketed predicate device to which equivalence is claimed.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, which is meant to represent the department's mission of protecting the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2003
Ms. Nancy Ring QA/RA Manager Diametrics Medical 2658 Patton Road Saint Paul, MN 55113-1136
Re: K030035
Trade/Device Name: IRMA® SL Blood Analysis System CR cartridge Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY Dated: April 11, 2003 Received: April 14, 2003
Dear Ms. Ring:
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. Iisting 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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Statement of Indications For Use
Intended Use
The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
Indications for Use
Creatinine measurements are used in the diagnosis and treatment of certain renal disease, and in monitoring renal dialysis.
(Please DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Prescription Use | OR | Over-The-Counter Use | |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Willis Sals' to Juan Cooper
(Division Sign-Division of Clinical Labor 510(k) Number