(135 days)
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No
The summary describes a standard in-vitro diagnostic test using affinity chromatography, with no mention of AI or ML terms or functionalities.
No
The device is an in-vitro diagnostic test used to monitor blood glucose levels, not for treating or preventing a disease.
Yes
The device is described as a "quantitative determination of HbA1c" which is an indicator for monitoring blood glucose levels in diabetics, aligning with the definition of a diagnostic device that measures a substance to assess a medical condition.
No
The device description clearly states it is an "in vitro test" and an "affinity chromatography method," which are laboratory techniques involving physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in-vitro quantitative determination of HbA1c in capillary blood". "In-vitro" means "in glass" or "outside the body", which is a key characteristic of IVDs.
- Device Description: The device description also states "in vitro test".
- Nature of the Test: The test analyzes a biological sample (blood) to provide information about a physiological state (HbA1c levels), which is the core function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
Instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin (GHb) in diabetics.
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Home use Test
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).
0
| 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) Submitter | ||
| name, address, | ||
| contact | Owner/ Operator | |
| Provalis Diagnostics Limited | ||
| Newtech Square | ||
| Deeside Industrial Park | ||
| Deeside | ||
| Flintshire CH5 2NT | ||
| UK | ||
| 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 20855 | ||
| USA | ||
| Telephone: | 301 330 2076 | |
| Facsimile: | 301 330 2568 | |
| Email: | ttsak@erols.com |
1
| 2) Device name | Proprietary name: | Glycosal™ II HbA1c Test | |
|---|---|---|---|
| Common name: | Prescription Home use Test for the | ||
| Detection of Glycated Hemoglobin in | |||
| Human Whole Blood. | |||
| Classification: | ASSAY, GLYCOSYLATED | ||
| HEMOGLOBIN | |||
| 3) Predicate | |||
| Device | The Glycosal™ II HbA1c test is substantially equivalent to | ||
| other 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) Device | |||
| Description | Instrument read, single use in vitro test for the quantitative | ||
| determination of glycated hemoglobin (GHb) in diabetics. | |||
| 5) Intended use | 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. |
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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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Page 2 -
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
4
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:
The Glycosal™ II HbA12 assay is an affinity chromatography method and is intended The Glycosal™ II HbAıs assay is an allindy Chromatography in capillary blood taken from a
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
sion Sygn-Only
ion of Clinical Laboratory Devices Koll933 510(k) Number