(27 days)
The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact Meter. The Accu-Chek Compact 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 system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
Instrument Operating Principle -- reflectance
Reagent Test Principle -- glucose dehydrogenase
The Accu-Chek Compact Test Strip (modified) demonstrates substantial equivalence to the legally marketed predicate device (Accu-Chek Compact Test Strip, predicate) based on performance testing that met predetermined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the comparison to the predicate device and the statement that "All predetermined acceptance criteria were satisfied." While explicit numerical acceptance criteria for each metric are not provided, the following table summarizes the reported performance of the modified device across various metrics, allowing for an implicit comparison to an assumed acceptable range.
| Metric | Acceptance Criteria (Implied by Predicate Performance and "All criteria satisfied") | Reported Device Performance (Modified Accu-Chek Compact Test Strip) |
|---|---|---|
| Test time | Likely acceptable if reduced or similar to predicate (15 seconds) | 8 seconds (Improved) |
| Minimum sample volume | Likely acceptable if reduced or similar to predicate (3.5 uL) | 1.5 uL (Improved) |
| Interference from triglycerides | Likely acceptable if higher or similar to predicate (> 1000 mg/dL) | > 5000 mg/dL (Improved) |
| Bilirubin | Likely acceptable if similar to predicate (> 20 mg/dL) | None (Improved, implies no interference at any level) |
| Fluoride | Likely acceptable if clearly defined as interfering, similar to predicate | Listed as interfering preservative in specimen collection section. |
| Accuracy (N=120) | Close correlation to laboratory reference, comparable to predicate (Y=0.954x+1.8, r=0.992) | Y=0.99x-1.96, Correlation coefficient = 0.983 |
| Range (Accuracy) | Comparable to predicate (64 - 350 mg/dL) | 56 - 531 mg/dL (Wider range) |
| Consumer Studies (N=120) | Close correlation, comparable to predicate (Y=0.956x+2.0, r=0.994) | Y=1.05x-5.065, Correlation coefficient = 0.983 |
| Range (Consumer Studies) | Comparable to predicate (63 - 359 mg/dL) | 56 - 531 mg/dL (Wider range) |
| Precision, aqueous, low | SD similar to predicate (1.0) | Mean = 43.2 mg/dL, SD = 1.0 (Comparable) |
| Precision, aqueous, mid | N/A (Predicate had data, modified did not claim) | None claimed |
| Precision, aqueous, high | %CV similar to predicate (2.4) | Mean = 339 mg/dL, %CV = 1.5 (Improved) |
| Precision, blood, low | SD similar to predicate (1.4) | Mean = 36 mg/dL, SD = 1.0 (Improved) |
| Precision, blood, mid | %CV similar to predicate (1.9) | Mean = 165 mg/dL, %CV = 1.4 (Improved) |
| Precision, blood, high | %CV similar to predicate (3.0) | Mean = 300 mg/dL, %CV = 1.5 (Improved) |
2. Sample Size Used for the Test Set and Data Provenance:
- Accuracy (Professional Use): N = 120
- Consumer Studies (Lay Use): N = 120
- Precision, aqueous: N = 10 for each level (low, high)
- Precision, blood: N = 10 for each level (low, mid, high)
- Data Provenance: Not explicitly stated, but the submission is from Roche Diagnostics Corporation in Indianapolis, IN, USA. The phrase "A multi-center performance study was conducted to evaluate the accuracy and precision" suggests potential multiple locations, but specific countries or retrospective/prospective nature are not detailed. However, given the context of a 510(k) submission for a glucose meter, it is highly likely these were prospective studies conducted to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study refers to a "laboratory plasma glucose reference test methodology" but does not specify the number or qualifications of experts involved in generating this reference or reviewing the 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:
This information is not applicable. The device is a glucose meter, not an AI-assisted diagnostic imaging or interpretation system requiring human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The study primarily evaluates the performance of the Accu-Chek Compact Test Strip (modified) system, which includes the strip and meter. The accuracy and precision figures provided represent the standalone performance of this system against a laboratory reference. While a human user is involved in collecting the sample and operating the device, the data presented (Y=mx+b equations, correlation coefficients, precision values) reflect the intrinsic performance of the device itself (the "algorithm" or measurement principle).
7. The Type of Ground Truth Used:
The ground truth for the accuracy studies was established using a laboratory plasma glucose reference test methodology. This implies a highly accurate and standardized laboratory method, typically a central lab analyzer, used to determine the true glucose concentration in the blood samples.
8. The Sample Size for the Training Set:
This information is not provided in the document. Glucose meters typically do not involve AI algorithms that require "training sets" in the conventional sense of machine learning. The device's performance is based on its chemical and optical components.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention of a "training set" for an AI algorithm in this context. The manufacturing process and quality control of the test strips and meter would be established against internal standards and reference materials.
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510(k) Summary
K031755
JUL 03 2003
| 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: Scott ThielDate Prepared: June 3, 2003, 2003 |
| 2) Device name | Proprietary name: Accu-Chek Compact 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 version ofthe same device. |
| 4) DeviceDescription | Instrument Operating Principle -- reflectanceReagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Compact Test Drums are used with the Accu-Chek CompactMeter. The Accu-Chek Compact system is designed to quantitativelymeasure the concentration of glucose in capillary and venous whole blood.The device is indicated for professional use and over-the-counter sale. TheAccu-Chek Compact system is indicated for lay person use with capillarywhole blood samples drawn from the fingertips, forearm, upper arm, thigh,calf, and palm. |
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The Roche Diagnostics Accu-Chek Compact Test Strip is substantially 6) Similarities equivalent to the current legally marketed version of the same device. The proposed modification is relatively modest 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 Compact Test Drums are used with the Accu-ChekCompact Meter. The Accu-Chek Compact system is designed toquantitatively measure the concentration of glucose in capillary andvenous whole blood. The device is indicated for professional use andover-the-counter sale. The Accu-Chek Compact system is indicated forlay person use with capillary whole blood samples drawn from thefingertips, forearm, upper arm, thigh, calf, and palm. |
| Test principle | Step 1: Glucose from the whole blood sample is oxidized by the PQQ-dependent enzyme glucose-dye-oxidoreductase to glucolactone and thereduction equivalents are transferred to the enzyme bound PQQ to give PQQH2.Step 2: The enzyme transfers the reduction equivalents from PQQH2 to theoxidized form of the mediator bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5-dienylidene)-ammonium chloride.Step 3: The reduced form of the mediator reduces the indicator 2,18-phosphomolybdic acid to produce the color heteropolyblue. |
| Monitor | Designed for use with the currently distributed version of the Accu-ChekCompact meter. |
| Monitor codingprocedure | Barcode containing coding information is printed on each drum of teststrips. |
| Test strip storageconditions | Store at room temperature between +36° F (+2° C) and +86° F (+30° C). |
| Test strip operatingconditions | Between +50° F (+10° C) and +104° F (+40° C). |
| Quality controltesting frequency | Tests should be run with liquid quality control materials whenever a newvial of test 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. Therange of the controls is within ± 15 mg/dL or ± 15% compared to thedetermined mean. |
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6) Similarities (continued)
| Feature/Claim | Detail |
|---|---|
| Labelinginstructionsregarding expectedresults | The normal fasting adult blood glucose range for a non-diabetic is 70-105 mg/dL. One to two hours after meals, normal blood glucose levels shouldbe less than 140 mg/dL. Doctors will determine the range that isappropriate for the patients. |
| Labelinginstructionsregarding responseto unusual results | Run a quality control test, if the result is outside the acceptable QCrecovery range contact Roche Diagnostics's Accu-Chek Customer Carecenter; if result is within the acceptable range, review proper testingprocedure and repeat blood glucose test with a new test strip. |
| Reagent stability | 18 months |
| Reportable range | 10-600 mg/dL |
| Hematocrit | 20 - 65 % |
| Acceptable sampletypes | Professional TestingCapillary whole blood samples (fingertip or alternative sites)Venous whole blood samplesLay User TestingCapillary whole blood samples (fingertip or alternative sites) |
| Warnings andprecautions | For in vitro diagnostic use only. |
| Reagentcomposition | Glucose-dye-oxidoreductase * Bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5-dienylidene)-ammonium chloride 2,18-phosphomolybdic acid Stabilizer Non-reactive ingredients *(from A. Calcoaceticus, recombinant from E. Coli) |
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Differences
| Feature | Accu-Chek Compact Test Strip(modified) | Accu-Chek Compact Test Strip(predicate) |
|---|---|---|
| Test time | 8 seconds | 15 seconds |
| Minimum samplevolume | 1.5 uL | 3.5 uL |
| Interference fromtriglycerides | > 5000 mg/dL | > 1000 mg/dL |
| Bilirubin | None | > 20 mg/dL |
| Fluoride | Listed as interfering preservative inspecimen collection section. | Listed as interfering preservative inspecimen collection and limitationssections. |
| Accuracy | N = 120Y=0.99x-1.96Correlation coefficient = 0.983Range = 56 - 531 mg/dL | N = 138Y=0.954x+1.8Correlation coefficient = 0.992Range = 64 - 350 mg/dL |
| Consumer Studies | N = 120Y=1.05x-5.065Correlation coefficient = 0.983Range = 56 - 531 mg/dL | N = 138Y=0.956x+2.0Correlation coefficient = 0.994Range = 63 - 359 mg/dL |
| Precision, aqueous,low | N = 10Mean = 43.2 mg/dLSD = 1.0 | N = 10Mean = 58.0 mg/dLSD = 1.0 |
| Precision, aqueous,mid | None claimed | N = 10Mean = 127.3 mg/dL%CV = 2.7 |
| Precision, aqueous,high | N = 10Mean = 339 mg/dL%CV = 1.5 | N = 10Mean = 227.7%CV = 2.4 |
| Precision, blood,low | N = 10Mean = 36 mg/dLSD = 1.0 | N = 20Mean = 56 mg/dLSD = 1.4 |
| Precision, blood,mid | N = 10Mean = 165 mg/dL%CV = 1.4 | N = 20Mean = 140 mg/dL%CV = 1.9 |
| Precision, blood,high | N = 10Mean = 300 mg/dL%CV = 1.5 | N = 20Mean = 390 mg/dL%CV = 3.0 |
:
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- Data demonstrating substantial equivalence
Performance testing on the modified Accu-Chek Compact Test Strip 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 Compact Test Strip correlates well with the laboratory plasma glucose reference test methodology. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Compact Test Strip is substantially equivalent to the predicate device.
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Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Scott Thiel Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
JUL 0 3 2003
Re: K031755
Trade/Device Name: Accu-Chek Compact Test Strip Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: LFR Dated: June 3, 2003 Received: June 6, 2003
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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Page 2 -
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K03 1755 "Special
Device Name: Accu-Chek Compact Test Strip
Indications for Use:
The Accu-Chek Compact Test Drums are used with the Accu-Chek Compact Meter. The Accu-Chek Compact 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-thecounter sale. The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | Jan Coogy |
|---|---|
| ------------------- | ------------------------------------------------------------ |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K031755 |
|---|---|
| -------- | ---------------------------------------------------------- |
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
ter 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.