(57 days)
The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact or Compact Plus Meter. The Accu-Chek Compact and Compact Plus system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Compact and Compact Plus system are indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System consists of the ACCU-CHEK Compact Plus Meter, ACCU-CHEK Compact Test Strips (provided separately), ACCU-CHEK Compact Control Solutions (provided separately), ACCU-CHEK Softclix lancing device, and ACCU- CHEK Softclix lancets. The ACCU-CHEK Compact Plus meter and ACCU-CHEK Softclix lancing device are modifications of the ACCU-CHEK Compact meter and ACCU- CHEK Softclix lancing device, respectively. There are no changes to other system testing components compared to the currently marketed product.
The information provided states that the ACCU-CHEK® Compact Plus Blood Glucose Monitoring System is substantially equivalent to the ACCU-CHEK Compact Blood Glucose Monitoring System. The key claim is "There has been no change to the performance characteristics of the system. A comparison of system accuracy performance demonstrated that the ACCU-CHEK Compact Plus system and the currently marketed ACCU-CHEK Compact system are substantially equivalent. The system maintains compliance with EN ISO 15197."
However, the provided text does not include specific acceptance criteria or the detailed study results (like accuracy metrics, sample sizes, ground truth establishment, etc.) that would typically be expected to demonstrate compliance with acceptance criteria for a medical device. Instead, it relies on the assertion of "no change to the performance characteristics" and substantial equivalence to a predicate device that is compliant with EN ISO 15197.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's a summary of what can and cannot be answered based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided text. However, the document claims the system "maintains compliance with EN ISO 15197." This standard would contain the specific accuracy requirements. | "There has been no change to the performance characteristics of the system.""A comparison of system accuracy performance demonstrated that the ACCU-CHEK Compact Plus system and the currently marketed ACCU-CHEK Compact system are substantially equivalent." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the study comparing the new device to the predicate.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document refers to "system accuracy performance" but does not detail how the ground truth reference values were obtained. For blood glucose measurements, this typically involves a laboratory reference method.
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Adjudication method for the test set:
- Not applicable as the ground truth is likely a quantitative lab measurement, not expert consensus requiring adjudication.
-
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 monitoring system, not an imaging or diagnostic device involving human readers/interpreters in the typical MRMC sense. The evaluation focuses on the accuracy of the device itself.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The evaluation described is inherently a standalone performance assessment of the device (meter and test strips) as it measures glucose concentration directly. The provided text, however, focuses on showing equivalence to the predicate device rather than detailing a new standalone performance study against a clinical reference.
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The type of ground truth used:
- While not explicitly stated, for blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods (e.g., YSI 2300 STAT Plus Glucose & Lactate Analyzer) rather than expert consensus, pathology, or outcomes data.
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The sample size for the training set:
- Not applicable. Blood glucose monitoring systems are typically validated directly for accuracy against a reference method. There isn't a "training set" in the machine learning sense for these types of devices; rather, it refers to the sample size of patient measurements used in the clinical study. This sample size is not specified.
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How the ground truth for the training set was established:
- Not applicable as there is no training set in the machine learning sense. For the performance assessment, the ground truth would be established by a laboratory reference method.
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ACCU-CHEK® Compact Plus Blood Glucose Monitoring System: 510(k) Summary
| Sponsor | Roche Diagnostic9115 Hague RoadIndianapolis, IN 46250 U.S.A. |
|---|---|
| Correspondent | Scott ThielRoche Diagnostic9115 Hague RoadIndianapolis, IN 46250Phone: (317)521-2000 |
| Device NameandClassification | ACCU-CHEK® Compact Plus Blood Glucose Monitoring SystemCommon Name: glucose test systemClassification:1. ACCU-CHEK Compact Plus Blood Glucose Meter and ACCU-CHEK Compact Test Strips are Class II devices (21 CFR § 862.1345)2. ACCU-CHEK Compact Control Solutions are a Class I device (21 CFR § 862.1600)3. ACCU-CHEK Softclix Lancing Device with ACCU-CHEK Softclix lancets are Class I (exempt) devices (21 CFR § 878.4800) |
| SystemDescription | The ACCU-CHEK Compact Plus Blood Glucose Monitoring System consists of the ACCU-CHEK Compact Plus Meter, ACCU-CHEK Compact Test Strips (provided separately), ACCU-CHEK Compact Control Solutions (provided separately), ACCU-CHEK Softclix lancing device, and ACCU- CHEK Softclix lancets.The ACCU-CHEK Compact Plus meter and ACCU-CHEK Softclix lancing device are modifications of the ACCU-CHEK Compact meter and ACCU- CHEK Softclix lancing device, respectively.There are no changes to other system testing components compared to the currently marketed product. |
| Continued on next page |
:
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ACCU-CHEK® Compact Plus Blood Glucose Monitoring System: 510(k) Summary, Continued
| PredicateDevice | ACCU-CHEK Compact Blood Glucose Monitoring System. |
|---|---|
| Intended Use | The ACCU-CHEK Compact Test Drums are used with the ACCU-CHEKCompact or Compact Plus Meter. The ACCU-CHEK Compact and CompactPlus systems are designed to quantitatively measure the concentration ofglucose in capillary and venous whole blood. The devices are indicated forprofessional use and over-the-counter sale. The ACCU-CHEK Compact andCompact Plus systems are indicated for lay use with capillary whole bloodsamples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm. |
| Comparison toPredicateDevice | The modifications to the device encompass:Meter: ergonomic/physical design and electronic/hardware changes. Lancing device: ergonomic/physical design Control solution: color |
| There have been no changes to the test strips, intended use, indications foruse, operating principle, or functionality. | |
| TechnologicalCharacteristics | There has been no change to the fundamental scientific technology. |
| Summary ofPerformanceCharacteristics | There has been no change to the performance characteristics of the system.A comparison of system accuracy performance demonstrated that the ACCU-CHEK Compact Plus system and the currently marketed ACCU-CHEKCompact system are substantially equivalent. The system maintainscompliance with EN ISO 15197.Design verification testing confirmed that the performance, safety, andeffectiveness of the ACCU-CHEK Compact Plus system are equivalent to thepredicate device. |
| Conclusion | The ACCU-CHEK Compact Plus system is substantially equivalent to thepredicate ACCU-CHEK Compact blood glucose monitoring system. |
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics c/o Mr. Scott Thiel Regulatory Affairs Program Manager 9115 Hague Road Indianapolis, IN 46256
JUL 1 5 2008
Re: K081389
Trade Name: ACCU-Chek Compact Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, LFR Dated: July 7, 2008 Received: July 8, 2008
Dear Mr. Thiel:
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) 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 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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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Indication for Use
510(k) Number (if known): K081389
Device Name: Accu-Chek Compact Plus Blood Glucose Monitoring System
Indication For Use:
The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact or Compact Plus Meter. The Accu-Chek Compact and Compact Plus system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale. The Accu-Chek Compact and Compact Plus system are indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K011389
§ 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.