(79 days)
The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary, venous and arterial blood samples; lay use is limited to capillary whole blood testing.
Instrument Operating Principle -- photometry Reagent Test Principle -- glucose dehydrogenase
The provided text describes the Accu-Chek Go System for measuring glucose concentration in whole blood. However, it does not detail specific acceptance criteria with numerical targets (e.g., accuracy percentages, bias limits) or provide the full study results with specific performance metrics against those criteria. The document is a 510(k) summary, which typically provides a high-level overview.
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions that "All predetermined acceptance criteria were satisfied," but it does not explicitly list the acceptance criteria or the specific reported device performance values for those criteria. It only states a general overarching acceptance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Device meets performance requirements for its intended use | "Performance testing on the modified Accu-Chek Go System demonstrated that the device meets the performance requirements for its intended use." |
| Accuracy and precision relative to reference method | "The clinical data demonstrates that the performance of the Accu-Chek Go correlates well with the laboratory plasma glucose reference test method, Glucose Hexokinase." |
| Substantial equivalence to predicate device | "All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Go is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document only mentions "A multi-center demonstrating substantial performance study was conducted."
- Data Provenance: Not specified. It only states a "multi-center" study. The terms "retrospective" or "prospective" are not used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified. The ground truth was established by a "laboratory plasma glucose reference test method, Glucose Hexokinase." There is no mention of human experts establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the ground truth was established by a laboratory reference method, not by human experts requiring adjudication.
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
Not applicable. This device is an in vitro diagnostic (glucose meter), not an imaging device or AI-assisted diagnostic tool that would involve "human readers" in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The performance study evaluated the device's (Accu-Chek Go System) accuracy and precision directly against a laboratory reference method. This is a standalone performance assessment of the device, as it measures the device's output independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used was a laboratory plasma glucose reference test method, specifically Glucose Hexokinase, with results converted to a plasma-like result.
8. The sample size for the training set
Not applicable. This device is a blood glucose meter, not a machine learning algorithm that typically requires a distinct "training set" in the context of AI/ML development. The "study" mentioned is a validation study for the device's performance.
9. How the ground truth for the training set was established
Not applicable for the same reason as
point 8.
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SEP - 2 2005
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) Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250 (317) 521-7688 Contact Person: Dimitris Demirtzoglou Date Prepared: June 14, 2005 |
| 2) Device name | Proprietary name: Accu-Chek Go System Classification name: Glucose dehydrogenase, glucose test system (21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicate device | We claim substantial equivalence to the current legally marketed Accu-Chek Go System (K#040796). |
| 4) Device Description | Instrument Operating Principle -- photometry Reagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale. |
| Professionals may use the test strips to test capillary, venous and arterial blood samples; lay use is limited to capillary whole blood testing. Capillary blood samples can be acquired from fingertips, forearm, upper arm, thigh, calf and palm. |
Continued on next page
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510(k) Summary, Continued
The Roche Diagnostics Accu-Chek Go (modified) System is substantially 6) Similarities equivalent to the current legally marketed Accu-Chek Go (predicate) System. 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 |
|---|---|
| Test principle | A glucose dye oxidoreductase mediator reaction.Step 1: Glucose is oxidized by the PQQ-dependent enzyme glucoe-dye-oxidoreductase (EC.1.1.99.17) to gluconolactone and the reductionequivalents are transferred to the enzyme-bound PQQ to give PQQH2.Step 2: The enzyme transfers the reduction equivalents from PQQH2 tothe oxidized form of the mediator. Bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5-dienylidene)-ammonium-chloride is used as amediator.Step 3: The reduced form of the mediator reduces the indicator 2,18-phosphomolybdic acid to produce the color heteropolyblue. |
| 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 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. |
| Labeling instructionsregarding expectedresults | The normal fasting adult blood glucose range for a non-diabetic is 74-106mg/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. |
| Labeling instructionsregarding response tounusual results | Run a quality control test, if the result is outside the acceptable QCrecovery range contact Roche Diagnostic'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. |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 25 - 65% |
| Warnings andprecautions | For in vitro diagnostic use only. |
Continued on next page
510(k) Summary, Continued
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6) Similarities (continued)
| Feature/Claim | Detail |
|---|---|
| Reagent stability | 18 months |
| Data transmission to external devices | Infrared interface |
| Reagent composition | Bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5-dienylidene)-ammonium-chloride Glucose dye oxidoreductase* 2,18-phosphomolybdic acid Stabilizer Nonreactive ingredients *(from A. Calcoaceticus, recombinant from E. Coli) |
| Alternate Site Test (AST) Claim | Both meter systems claim six testing sites, including: fingertip, upper arm, forearm, thigh, calf, and palm. Both meter systems include the same precautionary messaging relative to AST in the associated labeling. Both meter systems utilize the same optical detection system. Both meter systems utilize the same under dose detection technology and scheme. Both test strips have the same architecture and functional structure. |
| Meter physical dimensions | 113 x 46 x 20 mm |
| Batteries required | 1 lithium battery type CR2430 or DL2430 |
| Data Memory Capacity | 300 blood glucose results with date and time |
| Monitor coding procedure | Code chip provided with each carton of test strips. |
| Test time | Approximately 5 seconds |
| Method of preparing a test strip for a glucose test | User extracts a single test strip from a test strip vial and inserts the strip into the appropriate port in the meter until positioned correctly for a test. |
Continued on next page
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510(k) Summary, Continued
Differences
| Feature | Accu-Chek Go(modified) | Accu-Chek Go(predicate) |
|---|---|---|
| Intended use | The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale.Professionals may use the test strips to test capillary, venous and arterial blood samples; lay use is limited to capillary whole blood testing | The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale.Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. |
| Acceptable sample types | Capillary whole blood samples from a finger stick or AST site. Venous and arterial blood may also be used only if drawn by health care professionals. | Capillary whole blood samples from a finger stick or AST site. Venous blood may also be used only if drawn by health care professionals. |
Performance testing on the modified Accu-Chek Go System demonstrated that the 7) Data device meets the performance requirements for its intended use. A multi-center demonstrating substantial performance study was conducted to evaluate the accuracy and precision of the equivalence modified device. The study's objective was to evaluate the extent, to which results obtained from the system correlate to whole blood glucose reference that has been converted to a plasma-like result, using arterial whole blood. The clinical data demonstrates that the performance of the Accu-Chek Go correlates well with the laboratory plasma glucose reference test method, Glucose Hexokinase. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Go is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
SEP - 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Dimitris Demirtzoglou Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250
Re: K051592
Trade/Device Name: Accu-Chek Go test system Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR Dated: June 14, 2005 Received: June 15, 2005
Dear Mr. Demirtzoglou:
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) 276-0484. 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): K05 1592
Device Name: Accu-Chek Go Test System
Indications For Use:
The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale.
Professionals may use the test strips to test capillary, venous and arterial blood samples; lay use is limited to capillary whole blood testing.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) ANDYOR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PACL
(Division Division of Clini 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.