(15 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.
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
The provided text describes the Accu-Chek Active System and its substantial equivalence to a predicate device, focusing on features and intended use. However, it does not contain detailed information regarding the specific acceptance criteria, a comprehensive study report, sample sizes, expert qualifications, or ground truth establishment methods in the depth requested. The document is primarily a 510(k) summary and an FDA clearance letter.
Based on the available information, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All predetermined acceptance criteria were satisfied" but does not provide specific numerical acceptance criteria nor detailed reported device performance values. It only generally states that "The clinical data demonstrates that the performance of the Accu-Chek Active correlates well with the laboratory plasma glucose reference test method."
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (General Statement) |
|---|---|
| (Specific numerical criteria for accuracy, precision, etc., are not provided.) | "All predetermined acceptance criteria were satisfied." |
| "The clinical data demonstrates that the performance of the Accu-Chek Active correlates well with the laboratory plasma glucose reference test method." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: A "multi-center performance study" was conducted. The country of origin is not explicitly stated. It is a prospective study, as it was conducted to "evaluate the accuracy and precision of the modified device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified in the provided text.
4. Adjudication method for the test set
Not specified in the provided text.
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
- MRMC Study: Not applicable. This device is a glucose meter, an automated system, not an AI-assisted diagnostic imaging or interpretation system requiring human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
- Effect size of human reader improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a "multi-center performance study" was conducted to evaluate the accuracy and precision of the device itself, which operates as an algorithm-only system without human-in-the-loop performance for glucose measurement. The device's performance was compared to "the laboratory plasma glucose reference test method."
7. The type of ground truth used
The ground truth was established by a "laboratory plasma glucose reference test method." This implies comparison to a validated and accurate laboratory-based glucose measurement method.
8. The sample size for the training set
Not specified in the provided text. (For this type of device, what might be referred to as "training" would be part of the R&D and calibration process, not distinct in the same way as an AI model's training set).
9. How the ground truth for the training set was established
Not specified in the provided text. (As above, this information is not typically presented for a glucose meter in this format).
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JUN 2 0 2001
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Mike FlisDate Prepared: June 4, 2001 |
| 2) Device name | Proprietary name: Accu-Chek Active SystemClassification name: Glucose dehydrogenase, glucose test system(21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicatedevice | We claim substantial equivalence to the current legally marketed Accu-ChekSimplicity System. |
| 4) DeviceDescription | Instrument Operating Principle -- photometryReagent Test Principle -- glucose dehydrogenase |
| 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. |
Continued on next page
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The Roche Diagnostics Accu-Chek Active System is substantially equivalent 6) Similarities The Roone Diagnobile marketed Accu-Chek Simplicity System. The proposed to the current regarly manetees it in scope. The following is a list of some of the claims and features unaffected by the proposed modification.
| Feature/Claim | Detail |
|---|---|
| Intended use | The Accu-Chek Simplicity and Accu-Chek Active systems are designed toquantitatively measure the concentration of glucose in capillary whole blood.The test device is indicated for professional use and over-the-counter sale. Thisdevice is not suitable for testing neonate samples. |
| Test principle | Glucose dehydrogenase chemical reaction. The instrument measures the extentof color change (photometric) caused by the presence of glucose in the sample.The amount of color change is related to the glucose concentration in the bloodsample. |
| Venous blood samples | Although the method comparison studies provide evidence that the device worksacceptably with venous blood samples, the labeling is limited to use withcapillary whole blood. |
| Monitor codingprocedure | Code chip is provided with each carton of test strips. |
| Test strip storageconditions | Store at room temperature between +36° F(+2° C) and +86° F(+30° C). |
| Test strip operatingconditions | Between +5° F(+10° C) and +104° F(+40° C). |
| Quality control testingfrequency | Tests should be run with liquid quality control materials whenever a new vial oftest strips is opened or an unusual blood test result is obtained. |
| Quality controlacceptable range | The mean is strip lot specific and will be determined individually. The range ofthe controls is within ± 15 mg/dL or ± 15% compared to the determined mean. |
| Labeling instructionsregarding expectedresults | The normal fasting adult blood glucose range for a non-diabetic is 70-105mg/dL. One to two hours after meals, normal blood glucose levels should beless than 140 mg/dL. Doctors will determine the range that is appropriate for thepatients. |
| Labeling instructionsregarding response tounusual results | Run a quality control test, if the result is outside the acceptable QC recoveryrange contact Roche Diagnostics's Accu-Chek Customer Care center; if result iswithin the acceptable range, review proper testing procedure and repeat bloodglucose test with a new test strip. |
| Acceptable sampletypes | Capillary whole blood samples |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 30 - 55% |
| Warnings andprecautions | For in vitro diagnostic use only. |
Continued on next page
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510(k) Summary, Continued
- Data demonstrating substantial equivalence
Performance testing on the modified Accu-Chek Active System demonstrated that the device meets the performance requirements for its intended use. A multi-center performance study was conducted to evaluate the accuracy and precision of the modified device. The clinical data demonstrates that the performance of the Accu-Chek Active correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Active is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUN 2 0 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics corporation 9115 Hague Road Indianapolis, IN 46250
Re: 510(K) Number: K011738 Trade/Device Name: Accu-Chek Active Test System Regulation Number: 862.1345 Regulatory Class: II Product Code: NBW, LFR Dated: June 4, 2001 Received: June 5, 2001
Dear Mr. Flis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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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 predication. The 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 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, (Jease 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 Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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): Kou1738 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)
Fred Lacy
(Division Sign-Off Division of Clinica Laboratory Devices K011738 510(k) Number.
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.