(113 days)
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No
The summary describes a laboratory assay kit for measuring glycated serum proteins, which is a chemical/enzymatic process, and there is no mention of AI or ML in the provided text.
No
The device is an assay kit used for measuring glycated serum proteins, which is for monitoring diabetic patients, but it does not directly treat, prevent, or mitigate a disease or condition.
Yes
The device is intended for the quantitative determination of glycated serum proteins (GSP) in serum, and this measurement is useful for monitoring diabetic patients, indicating its role in diagnosis and disease management.
No
The provided text describes an "Assay Kit" and a "single calibrator," which are physical components used for quantitative determination of glycated serum proteins. This indicates the device includes hardware (reagents, calibrator) and is not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "quantitative determination of glycated serum proteins (GSP; glycated albumins; fructosamine) in serum." This involves testing a biological sample (serum) in vitro (outside the body).
- Purpose: The measurement is stated to be "useful for monitoring diabetic patients," indicating a medical purpose related to diagnosis, monitoring, or treatment.
- Components: The description mentions a "single calibrator" and "controls," which are typical components of IVD assay kits used for accurate measurement and quality control.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
Diazyme Glycated Serum Protein Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator is intended for the quantitative determination of glycated serum proteins (GSP; glycated albumins; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients.
Diazyme Glycated Serum Protein Assay is used with a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples,
Diazyme Glycated Serum Protein Assay has controls for normal glycated serum protein level and abnormal glycated serum protein level. The controls are used as reference samples for checking the functionality of the Diazyme Glycated Serum Protein Enzymatic Assay.
Product codes
LCP, JIT, JJX
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): 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.
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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.
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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).
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§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
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Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 1 7 2011
Diazyme Laboratories c/o Mr. Abhijit Datta 12889 Gregg Court Poway, CA 92064
Re: K110188
Trade/Device Name: Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP, JIT, JJX Dated: April 11, 2011 Received: April 18, 2011
Dear Mr. Datta:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to party at the notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its the number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
:沙沙
Enclosure
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Indication for Use
KI10188 510(k) Number (if known):
Device Name: Diazyme Glycated Serum Protein Assay Diazyme Glycated Serum Protein Calibrator Kit Diazyme Glycated Serum Protein Control Kit
Indication for Use:
Diazyme Glycated Serum Protein Assay Kit in conjunction with Diazyme Glycated Serum Protein single calibrator is intended for the quantitative determination of glycated serum proteins (GSP; glycated albumins; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients.
Diazyme Glycated Serum Protein Assay is used with a single calibrator. The calibrator is used in the calculation of glycated serum protein concentrations in unknown serum samples,
Diazyme Glycated Serum Protein Assay has controls for normal glycated serum protein level and abnormal glycated serum protein level. The controls are used as reference samples for checking the functionality of the Diazyme Glycated Serum Protein Enzymatic Assay.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol Benson
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device
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