(135 days)
The Glycosal™ II HbA1c test is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The Glycosal™ II HbA1c test is intended for use as a prescription home use test.
Instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin (GHb) in diabetics.
Below is a summary of the acceptance criteria and study information for the Glycosal™ II HbA1c Test, based on the provided text.
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on obtaining FDA clearance through substantial equivalence to predicate devices (Glycosal™ HbA1c test and Metrika DRX HbA1c) rather than defining specific numerical acceptance criteria for performance. The "reported device performance" would therefore typically involve demonstrating comparable accuracy, precision, and other assay characteristics to these predicate devices. However, explicit numerical acceptance criteria for performance (e.g., specific CV%, bias, correlation coefficients) and their direct fulfillment are not detailed in the provided text. The text indicates the device is an "instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin (GHb) in diabetics," and the intended use is for "monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document as numerical performance goals. The primary "acceptance" was FDA's determination of substantial equivalence to predicate devices, implying comparable safety and effectiveness. | Performance data, while likely submitted to FDA for the 510(k), is not detailed in this summary. The device was deemed "substantially equivalent" to predicate devices, meaning its performance was considered comparable for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: Not specified in the provided text.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. The Glycosal™ II HbA1c Test is an in-vitro diagnostic (IVD) quantitative assay, not an imaging interpretation device.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study: The device is described as an "instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin." This implies that the device operates as a standalone system (algorithm/assay only) to provide a quantitative result. Therefore, a standalone performance study, demonstrating the accuracy and precision of the assay in producing the HbA1c value, would have been necessary for the 510(k) submission, even if the details are not explicitly provided in this summary.
7. Type of Ground Truth Used:
- Type of Ground Truth: For quantitative in-vitro diagnostics like HbA1c tests, the "ground truth" would typically be established using reference methods or highly accurate, clinically accepted laboratory assays for glycated hemoglobin (HbA1c) on the same blood samples. This is not explicitly stated in the provided text, but it is the standard practice for validating such devices.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable/Not specified in the provided text. This device is an in-vitro diagnostic assay based on affinity chromatography, not an AI/ML algorithm that requires a training set in the conventional sense. Its performance is determined by the biochemical properties of the assay and the calibration of the instrument, not by machine learning from a data set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable as there is no mention of an AI/ML training set as this is an in-vitro diagnostic assay.
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| NOV 0 2 2001 510(k) Summary of safety and Effectiveness | ||
|---|---|---|
| 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. | |
| 1) Submittername, address,contact | Owner/ OperatorProvalis Diagnostics LimitedNewtech SquareDeeside Industrial ParkDeesideFlintshire CH5 2NTUK | |
| Contact Person: | Mrs Jan Barrack, Regulatory Affairs Manager | |
| Telephone: | +44 1244 288888 | |
| Facsimile: | +44 1244 280221 | |
| Email: | JanBarrack@Provalis.com | |
| USA contact person | Thomas M Tsakeris | |
| Company | Devices and Diagnostics Consulting Group Inc. | |
| Address: | 16809 Briardale Road,Rockville,MD 20855USA | |
| Telephone: | 301 330 2076 | |
| Facsimile: | 301 330 2568 | |
| Email: | ttsak@erols.com |
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| 2) Device name | Proprietary name: | Glycosal™ II HbA1c Test | |
|---|---|---|---|
| Common name: | Prescription Home use Test for theDetection of Glycated Hemoglobin inHuman Whole Blood. | ||
| Classification: | ASSAY, GLYCOSYLATEDHEMOGLOBIN | ||
| 3) PredicateDevice | The Glycosal™ II HbA1c test is substantially equivalent toother products in commercial distribution for similar use,including the Glycosal™ HbA1c test (primary predicate device)and the Metrika DRX HbA1c, for prescription home use test(secondary predicate device). | ||
| 4) DeviceDescription | Instrument read, single use in vitro test for the quantitativedetermination of glycated hemoglobin (GHb) in diabetics. | ||
| 5) Intended use | The Glycosal™ II HbA1c test is an affinity chromatographymethod and is intended for the in-vitro quantitativedetermination of HbA1c in capillary blood taken from a fingerprick. | ||
| The test is indicated for use by diabetics for monitoring the timeaveraged blood glucose levels of known diabetics as anindicator of overall glycaemic control. | |||
| The Glycosal™ II HbA1c test is intended for use as aprescription home use test. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Provalis Diagnostics Ltd. NOV 0 2 2001 c/o Mr. Thomas M. Tsakeris Devices and Diagnostics Consulting Group 16809n Briardale Road Rockville, MD 20855
K011933 Re:
Trade/Device Name: Glycosal™ II HbA1c Test Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: September 19, 2001 Received: September 20, 2001
Dear Mr. Tsakeris:
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 for ass been and 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 notification. The FDA inding of succeantary of successity of this, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 If you desire specific article your do novelses), please contact the Office of Compliance at additionally 607.10 for in This alaglestions on the promotion and advertising of your device, (301) 594-4536. Rudationally, 2011 452-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and Consumer Assistance at its toll-free number (800) 638-2041 or Mandracturers International and Colabor. "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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NOV 0 2 2001
Intended Use/Indications for Use Statement
Unknown-not yet assigned by FDA 510(k) Number:
Glycosal™ II HbA1c Test Device Name:
Intended Use/Indications for Use Statement:
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for the in-vitro quantitative determination of HbAıs in capillary blood taken from finger prick.
The test is indicated for monitoring the time averaged blood glucose levels of known The test is indicated for monitoning the time avolugue are a seems.
diabetics, for use at home by diabetics as an indicator of overall glycaemic control.
The Glycosal™ II HbA1e assay is intended for prescription home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qurhim-Bautista
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ion of Clinical Laboratory Devices Koll933 510(k) Number
§ 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).