(89 days)
No
The summary describes a system for measuring cholesterol and glucose using test strips and does not mention any AI or ML components.
No.
The device is designed to measure cholesterol and glucose levels, which are diagnostic indicators, not therapeutic treatments.
Yes
The device is intended to quantitatively measure cholesterol and glucose, which are used to monitor health conditions, making it a diagnostic device.
No
The device description explicitly states it is a "Dual Testing System" that uses "test strips" to measure cholesterol and glucose in "capillary whole blood." This indicates the presence of physical components (the system itself and the test strips) that interact with a biological sample, making it a hardware-based medical device, not software-only.
Yes, based on the provided information, the AccuChek® Instant Plus Dual Testing System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to "quantitatively measure cholesterol and glucose in capillary whole blood." This involves testing biological samples (whole blood) outside of the body to provide information about a person's health status. This is a core characteristic of IVDs.
- Device Description: The description explicitly mentions "test strips" for measuring specific analytes (glucose and cholesterol) in whole blood. Test strips used for diagnostic purposes on biological samples are a common component of IVD systems.
- Regulatory Context: The mention of 510(k) submissions (K944458 and K944459) for the individual test strips and the dual system indicates that this device has gone through the regulatory process for medical devices, specifically those
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, CHH
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.
Mentions image processing
Not Found
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
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.
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.
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).
Not Found
§ 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.
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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