(21 days)
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Not Found
No
The summary describes calibrators for HbA1c measurement, which are passive components used in conjunction with instruments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on calibration standards.
No
This device is for in vitro diagnostic use only and is explicitly stated as for "measurement of HbA1c," which indicates a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."
No
The 510(k) summary describes calibrators for in vitro diagnostic use, which are physical substances used to calibrate instruments. This indicates a hardware component, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The key phrase that confirms this is:
"For in vitro diagnostic use only."
This statement explicitly indicates that the device is intended for use in testing biological samples outside of the body to diagnose or monitor a medical condition. The description of its use with instruments for measuring HbA1c further supports its role in clinical diagnostics.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only. These calibrators are intended for use with instruments for the measurement of HbA1c and are designed to allow calibration to either the American NGSP system or the International IFCC system.
Product codes
JIT
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 9 2004
Miss Diane Hill R&D Biochemist Drew Scientific Ltd. Sowerby Woods, Industrial Estate Park Road Barrow-in Furness Cumbria LA14 4QR UK
Re: K043378
Trade/Device Name: Drew Scientific Ltd., Glycated Haemoglobin Two Level Calibrator Kit Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: December 03, 2004 Received: December 08, 2004
Dear Miss Hill:
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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) rms let 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 (240)276-0484. 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 Pouring, 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/industry/support/index.html
Sincerely yours,
ctore
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number: | K043378 |
|---|---|
| Device Name: | Drew Scientific Ltd., Glycated Haemoglobin Two Level Calibrator Kit. |
| Indications For Use: | For in vitro diagnostic use only. These calibrators are intended for use with instruments for the measurement of HbA1c and are designed to allow calibration to either the American NGSP system or the International IFCC system. |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
petini
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K043378
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