(25 days)
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No
The summary describes a chemical reagent for laboratory testing, with no mention of AI or ML technologies.
No
The device is a reagent for diagnostic testing and does not directly provide therapy. Its results are used in diagnosis and treatment, but the reagent itself is not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The results are used in the diagnosis and treatment of renal malfunction," indicating its role in diagnosis.
No
The device description clearly states "Creatinine Reagent," which is a chemical substance used in laboratory testing, not a software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of serum creatinine." This involves testing a biological sample (serum) outside of the body.
- Purpose: The results are used in the "diagnosis and treatment of renal malfunction," which is a medical purpose.
- Device Description: It's a "Creatinine Reagent," which is a substance used in a laboratory test.
These characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Creatinine Reagent is intended for the quantitative determination of serum creatinine using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of renal malfunction.
Product codes
CGX
Device Description
Creatinine Reagent
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
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Key Metrics
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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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized design of an eagle or bird-like figure. The design is composed of thick, curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 7 1997
Cynthia Shugart · President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821
K971908 Re : Creatinine Reagent Regulatory Class: II Product Code: CGX Dated: May 9, 1997 May 23, 1997 Received:
Dear Ms. Shuqart:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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.
今 If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_3 of_32
510(k) Number (if known): K971908
Device Name: Creatinine Reagent ·
Indications For Use:
Creatinine Reagent is intended for the quantitative ે છ determination of serum creatinine using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of renal malfunction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971908 |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | __________ |
|---|---|
| ---------------------- | ------------ |
(Optional Format 1-2-96)