(89 days)
The AccuChek® Instant Plus Dual Testing System is designed to quantitatively measure cholesterol and glucose in capillary whole blood. The AccuChek Instant Glucose Test Strips are for use in home and professional settings for testing glucose in whole blood. The AccuChek Instant Cholesterol Test Strips are for use by health care professionals and for home use by people with diabetes for cholesterol screening.
The AccuChek Instant Plus system had each parameter (cholesterol and glucose) cleared separately. Since the device can use either the glucose test strip or the cholesterol test strip, the agency considers this dual testing system a new device which requires data to prove that users can distinguish between the two test strips. The AccuChek Instant Plus Dual Testing System has not been modified. The performance data for the individual test strip type can be found in the following 510(k) submissions: AccuChek Instant Plus Cholesterol Test Strip: K944458 AccuChek Instant Plus Glucose Test Strip: K944459 In addition, the agency's request does not impact the performance data submitted in the previous 510(k) submissions; however, a new additional study was performed to answer the concerns expressed by the agency.
This document describes the AccuChek Instant Plus Dual Testing System, which measures both cholesterol and glucose. The key aspect of this submission is to demonstrate that users can distinguish between the two types of test strips.
1. Table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not include specific acceptance criteria for distinguishing between the two test strips, nor does it explicitly report performance against such criteria. The document states that the agency requested a new additional study to answer concerns expressed by the agency regarding users distinguishing between the two test strips. However, the results of this study are not presented in the provided text.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given information. The document focuses on the regulatory submission and intent, rather than detailed study results.
2. Sample size used for the test set and the data provenance
The document mentions that a "new additional study was performed to answer the concerns expressed by the agency" regarding distinguishing between the two test strips. However, the sample size used for this test set and the data provenance (e.g., country of origin, retrospective/prospective) are not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study mentioned is related to user distinction of test strips, not expert interpretation of results.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The device described is a blood glucose and cholesterol meter, not an AI-powered diagnostic imaging tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with or without AI assistance is not applicable and not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. Given the nature of a handheld testing system, a "standalone algorithm only" performance without a human in the loop for operating the device might not be directly relevant in the same way as for an AI diagnostic algorithm. The primary concern here is the user's ability to differentiate between the physical test strips.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the specific "new additional study" concerning users distinguishing between test strips, the "ground truth" would likely involve direct observation of user behavior or a verified method of identifying which strip type was being used. For example, the ground truth could be the actual type of test strip (glucose or cholesterol) used in a simulated or real testing scenario. However, this information is not explicitly stated in the provided text.
For the performance of the glucose and cholesterol measurements themselves, the ground truth would have been established during the original 510(k) submissions (K944458 and K944459) for each individual parameter, likely through comparison with laboratory reference methods or established standards. This specific document, however, does not detail those ground truth methods.
8. The sample size for the training set
The document mentions a "new additional study" to address user distinction of test strips, but it does not refer to a "training set" in the context of an algorithm or machine learning model. Therefore, this information is not applicable or provided.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of an algorithm, this information is not applicable or provided.
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| 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 | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 |
| Contact Person: Jennifer Tribbett | |
| Date Prepared: May 25, 2005 | |
| 2) Device name | Proprietary name: AccuChek® Instant Plus Dual Testing System Common name: Glucose and Cholesterol Classification name: Glucose Oxidase, Glucose and Enzymatic Esterase-Oxidase, Cholesterol. |
| 3) Predicate device | The AccuChek Instant Plus Dual Testing System is substantially equivalent to the AccuChek Instant Plus System described in both K944458 and K944459. |
| 4) Device Description | The AccuChek Instant Plus system had each parameter (cholesterol and glucose) cleared separately. Since the device can use either the glucose test strip or the cholesterol test strip, the agency considers this dual testing system a new device which requires data to prove that users can distinguish between the two test strips. |
| The AccuChek Instant Plus Dual Testing System has not been modified. The performance data for the individual test strip type can be found in the following 510(k) submissions: | |
| AccuChek Instant Plus Cholesterol Test Strip: K944458 | |
| AccuChek Instant Plus Glucose Test Strip: K944459 | |
| In addition, the agency's request does not impact the performance data submitted in the previous 510(k) submissions; however, a new additional study was performed to answer the concerns expressed by the agency. |
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- The AccuChek® Instant Plus Dual Testing System is designed to 5) Intended use quantitatively measure cholesterol and glucose in capillary whole blood. The AccuChek Instant Glucose Test Strips are for use in home and professional settings for testing glucose in whole blood. The AccuChek Instant Cholesterol Test Strips are for use by health care professionals and for home use by people with diabetes for cholesterol screening.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
AUG 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Tribbett Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250
K051376 Re:
Trade/Device Name: AccuChek Instant Plus Dual Testing System Regulation Number: 21 CFR 862.1345 Glucose test system Regulation Name: Regulatory Class: Class II Product Code: NBW, CGA, CHH Dated: May 25, 2005 Received: May 26, 2005
Dear Ms. Tribbett:
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) I mis lotter will anow you w ough finding of substantial equivalence of your device to a legally premated 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 Division 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,
Carol C. Benem
Carol C. Benson, M.A. 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 (if known): K051374
AccuChek® Instant Plus Dual Testing System Device Name:
Indications For Use:
The AccuChek® Instant Plus Dual Testing System is designed to quantitatively measure cholesterol and glucose in capillary whole blood. The AccuChek Instant Glucose Test Strips are for use in home and professional settings for testing glucose in whole blood. The AccuChek Instant Cholesterol Test Strips are for use by health care professionals and for home use by people with diabetes for cholesterol screening.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CA
Division 510(k) Numbe Page 1 of
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.