(305 days)
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No
The summary describes a chemical reagent for quantitative determination of Creatinine, with no mention of AI or ML.
No
The device is a reagent intended for in vitro diagnostic (IVD) use to quantify creatinine, which aids in diagnosis and monitoring, but does not directly treat a condition.
Yes
Explanation: The device is used to diagnose and monitor renal impairment, which directly relates to diagnosing a medical condition.
No
The 510(k) summary describes a reagent for in vitro diagnostic testing, which is a chemical substance used in a laboratory setting, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Thermo Electron Enzymatic Creatinine reagent is intended for the in vitro quantitative determination of Creatinine in human serum, plasma or urine."
The phrase "in vitro quantitative determination" is a key indicator of an IVD. IVDs are used to examine specimens taken from the human body (like serum, plasma, or urine in this case) outside of the body ("in vitro") to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
The Thermo Electron Enzymatic Creatinine reagent is intended for the in vitro quantitative determination of Creatinine in human serum, plasma or urine. Creatinine determinations are used in the diagnosis and treatment of renal impairment, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Product codes
JFY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 3 2007
Re: K061412
Bola Nicholson
171 Industry Drive Pittsburgh, PA 15275
Thermo Electron Corporation
Trade Name: Thermo Electron Enzymatic Creatinine Reagent Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Code: JFY Dated: March 02, 2007 Received: March 05, 2007
Dear Ms. Nicholson:
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).
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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 1 logally marketed predicate device results in a classification for your device and thus, persons of rough 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 (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 no (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
2
Indications for Use
510(k) Number K061412:
Device Name:
-
- Thermo Electron Enzymatic Creatinine reagent.
Indications for Use:
-
- The Thermo Electron Enzymatic Creatinine reagent is intended for the in vitro quantitative determination of Creatinine in human serum, plasma or urine. Creatinine determinations are used in the diagnosis and treatment of renal impairment, in monitoring renal dialysis, and as a calculation basis for measuring
other urine analytes.
- The Thermo Electron Enzymatic Creatinine reagent is intended for the in vitro quantitative determination of Creatinine in human serum, plasma or urine. Creatinine determinations are used in the diagnosis and treatment of renal impairment, in monitoring renal dialysis, and as a calculation basis for measuring
Prescription Use (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)
Division Sign-Off
Office of In Vitro Diagnostic Device age 1 of 1 Tvaluation and Safety