(135 days)
The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.
The Accu-Chek Active Test System includes a handheld meter, lancet device, lancets, and instructions for use. Test strips and liquid controls may be acquired separately.
The provided text (K012324 for the Accu-Chek Active Test System) is a 510(k) summary for a blood glucose test system. It focuses on establishing substantial equivalence to predicate devices for its intended use, particularly for an Alternate Site Testing (AST) claim.
However, the document does not contain the detailed information necessary to fully answer all aspects of your request. Specifically, it lacks a dedicated section outlining acceptance criteria, rigorous performance study results with specific sample sizes, expert ground truth establishment, or statistical methods.
Blood glucose meters are typically evaluated against ISO 15197 standards for accuracy, but this document does not explicitly state those standards as acceptance criteria or present data in that format.
Based on the available information, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format. However, the overall implication of a 510(k) submission is to demonstrate that the device performs as well as or similarly to legally marketed predicate devices.
The "Comparison to Predicate Devices" table provides a qualitative comparison of features, including the AST claim, but no quantitative performance metrics.
Study Details (Based on available information)
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms within this document. For blood glucose meters, general acceptance is usually tied to meeting analytical accuracy performance standards (e.g., ISO 15197), but these are not listed.
- Reported Device Performance: No specific quantitative performance data (e.g., accuracy percentages, bias, or precision studies) are provided in this summary. The summary focuses on comparing features and intended use to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in this 510(k) summary (e.g., specific accuracy metrics from ISO 15197) | No quantitative performance data provided in this 510(k) summary. |
| Substantial equivalence to predicate devices for intended use and features (including AST) | Qualitatively deemed substantially equivalent based on intended use and features listed in comparison table. |
| AST (Alternate Site Testing) capability at forearm only |
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. For blood glucose meters, "ground truth" would typically come from a recognized laboratory reference method (e.g., YSI analyzer), rather than expert consensus on images.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the study type and performance data are not described.
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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:
- Not applicable. This is a blood glucose meter, not an AI-based imaging diagnostic device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the context of an AI algorithm. For a medical device like a blood glucose meter, "standalone performance" refers to the analytical accuracy of the device itself against a reference method. While such studies would have been performed, the details are not included in this 510(k) summary.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated, but for blood glucose meters, the "ground truth" or reference method is invariably an established laboratory method (e.g., a YSI glucose analyzer) that is well-calibrated and highly accurate.
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The sample size for the training set:
- Not applicable. This is a blood glucose meter, not a device using machine learning with a distinct "training set."
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How the ground truth for the training set was established:
- Not applicable.
Summary of Missing Information:
This 510(k) summary primarily serves to establish "substantial equivalence" based on intended use and features, rather than providing a detailed report of clinical or analytical performance study results. Key details regarding sample sizes, specific performance metrics, the methodology of accuracy studies, and the reference methods used as "ground truth" are not included in this publicly available summary document. These details would typically be found in the full submission to the FDA, but not in the abbreviated 510(k) summary.
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Accu-Chek Active Test System
| DEC 0 5 2001 | 510(k) Summary |
|---|---|
| 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 | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Mike FlisDate Prepared: July 20, 2001 |
| 2) Device name | Proprietary name: Accu-Chek Active Test SystemCommon name: Blood glucose test systemClassification name: glucose dehydrogenase, glucose |
| 3) Predicatedevice | The Roche Diagnostics Accu-Chek Active Test System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the recently cleared version of the same product. In addition, the AST claim described in this 510(k) premarket notification is substantially equivalent to claims cleared for the following medical devices. Lifescan/Inverness One Touch Ultra Test System (K002134-Special)Abbott/Medisense Sof-Tact Test System (K001993-Traditional)Therasense Freestyle Test System (K992684-Traditional)Lifescan/Inverness FastTake Test System (K001427-Special) |
| 4) DeviceDescription | The Accu-Chek Active Test System includes a handheld meter, lancet device, lancets, and instructions for use. Test strips and liquid controls may be acquired separately. |
| Continued on next page |
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510(k) Summary, Continued
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| 5) Intended use | The Accu-Chek Active system is designed to quantitatively measure theconcentration of glucose in capillary whole blood. The device is indicated forprofessional use and over-the-counter sale. |
|---|---|
| 6) Comparisonto predicatedevice | The Accu-Chek Active Test System is substantially equivalent to otherproducts in commercial distribution intended for similar use. |
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omparison to Predicate Devices
| Accu-ChekActive with AST | Accu-ChekActive | AmiraAtLast | TherasenseFreestyle | MedisenseSof-Tact | Lifescan OneTouch Ultra | LifescanFastTake | |
|---|---|---|---|---|---|---|---|
| 510(k)(T) = Trad.(S) = Special | K011738 (S) | K982076 (T) | K992684 (T)& K000582 (S) | K001993 (T) | K002134 (S) | K001427 (S) | |
| 510(k) SponsorIntended Use | RocheBlood glucosemonitoring | RocheBlood glucosemonitoring | AmiraBlood glucosemonitoring | TherasenseBlood glucosemonitoring | AbbottBlood glucosemonitoring | InvernessBlood glucosemonitoring | InvernessBlood glucosemonitoring |
| OTC sale | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Minimum samplevolume required(µL) | 1 | 1 | 2 | 0.3 | 3 | 1 | 1.5 |
| Fingertip | Yes | Yes | No | Yes | Yes | Yes | Yes |
| AST | Yes | No | Yes | Yes | Yes | Yes | Yes |
| AST limited toforearm only | Yes | NA | No | No | No | Yes | Yes |
| Underdosingdetection | Yes | Yes | Yes | Yes | No | No | Yes |
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Image /page/3/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 curved lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
DEC 0 5 2001
Re: K012324
Trade/Device Name: Accu-Chek Active Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: November 8, 2001 Received: November 13, 2001
Dear Mr. Flis:
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 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 predicate device results in a classification for your device and thus, 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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Indications for Use Statement
510(k) Number (if known): Device Name: Accu-Chek Active Test System
Indications for Use:
The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off)Division of Clinical Laboratory Devices | |
| 510(k) Number | K012324 |
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.