(7 days)
Not Found
No
The description details a standard enzymatic assay for creatinine measurement and does not mention any AI or ML components.
No
This device is an in vitro diagnostic reagent system used for quantitative determination of creatinine concentration, which aids in diagnosis rather than providing treatment.
Yes
The "Intended Use / Indications for Use" section states that the device is an "in vitro diagnostic reagent system."
No
The device description clearly states it is an "in vitro diagnostic reagent system" and an "enzymatic method," indicating it involves physical reagents and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine."
This statement clearly identifies the device as an in vitro diagnostic reagent system.
N/A
Intended Use / Indications for Use
The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Product codes
JFY
Device Description
The COBAS Integra Creatinine plus ver. 2 Assay is an enzymatic method based on the determination of hydrogen peroxide after conversion of creatinine with the aid of creatininase, creatinase, and sarcosine oxidase. The liberated hydrogen peroxide reacts to form a quinone imine dye, the color intensity of which is directly proportional to the creatinine 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
Adults
Children: Neonates (premature), Neonates (full term), 2 - 12 m, 1 -
§ 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 - COBAS Integra Creatinine plus ver.2 Assay
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3831 |
Contact person: Sherri L. Coenen
Date prepared: December 11, 2002 |
| Device Name | Proprietary name: COBAS Integra Creatinine plus ver.2
Common name: creatinine reagent
Classification name: enzymatic Method, Creatinine |
| Device description | The COBAS Integra Creatinine plus ver. 2 Assay is an enzymatic method based on the determination of hydrogen peroxide after conversion of creatinine with the aid of creatininase, creatinase, and sarcosine oxidase. The liberated hydrogen peroxide reacts to form a quinone imine dye, the color intensity of which is directly proportional to the creatinine concentration. |
| Intended use | The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine. |
| Predicate Device | We claim substantial equivalence to the currently marketed COBAS Integra Creatinine plus Assay. (K003261). |
1
510(k) Summary - COBAS Integra Creatinine plus ver.2,
continued
Reagent Summary
The following table describes the similarities and differences between the COBAS Integra Creatinine plus ver.2 assay and the predicate device.
| Topic | COBAS Integra
Creatinine plus
(K003261) | COBAS Integra
Creatinine plus ver.2
(Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS INTEGRA
Creatinine plus (CREAP)
contains an in vitro diagnostic
reagent system intended for use
on COBAS INTEGRA systems
for the quantitative determination
of the creatinine concentration in
serum, plasma, and urine. | The cassette COBAS INTEGRA Creatinine
plus ver.2 (CREP2) contains an in vitro
diagnostic reagent system intended for use on
COBAS INTEGRA systems for the
quantitative determination of the creatinine
concentration in serum, plasma, and urine. |
| Method | Enzymatic colorimetric | Same |
| Sample type | serum, plasma (Li-heparin, K3-
EDTA), urine | Same |
| Measuring
range | Serum/Plasma: 0 - 2700 µmol/L
Urine: 0 - 40 mmol/L | Same |
| Expected
values | Serum/Plasma:
Females: 45 - 84 µmol/L
Males: 59 - 104 µmol/L | Serum/Plasma:
Adults
Females: 45 - 84 µmol/L
Males: 59 - 104 µmol/L
Children
Neonates (premature): 29 - 87 µmol/L
Neonates (full term): 27 - 77 µmol/L
2 - 12 m: 14 - 34 µmol/L
1 - Trade/Device Name: COBAS Integra Creatinine plus ver.2 Assay Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY Dated: December 11, 2002 Received: December 12, 2002
Dear Ms. Coenen:
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).
4
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). Other general information on your responsibilities under the Act may be obtained 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
5
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: COBAS Integra Creatinine plus ver.2 Assay
Indications For Use:
The cassette COBAS INTEGRA Creatinine plus ver.2 (CREP2) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Dean Cooper
(Division Sign-Off) (Division of Clinical Laboratory Devices 以 510(k) Number ..
(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)