(66 days)
The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.
Instrument Operating Principle -- photometric
Reagent Test Principle -- glucose deoxy reductase
The provided text describes the Glucotrend™ Basic System, a self-monitoring blood glucose test system. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance and then proving that the device meets those criteria.
However, the "Performance Characteristics" section provides data that would typically be used to assess accuracy and precision, which can be interpreted as the device's reported performance against implicit expectations for a blood glucose monitor.
Here's an attempt to structure the information based on your request, understanding that explicit acceptance criteria are not stated.
Interpretation of "Acceptance Criteria" from the provided text:
Since explicit acceptance criteria are not given, we can infer that the device's performance is being benchmarked against the predicate device (Accu-Chek Advantage System) and generally accepted standards for blood glucose monitors at the time of submission (1997), particularly in terms of accuracy (correlation with reference methods) and precision (reproducibility). Regulatory bodies typically have guidance documents outlining acceptable performance ranges for such devices, even if not explicitly stated in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | "Acceptance Criteria" (Inferred/Benchmark) | Reported Device Performance (Glucotrend™ Basic System) |
|---|---|---|
| Accuracy | (Implicitly similar to predicate and within acceptable clinical deviation from reference method) | |
| Trained HCP vs. Reference (Capillary Blood) | Correlation (r) > 0.973, Slope (y) approx. 0.99x-1.0x, Intercept (b) approx. 5.0 (based on predicate) | N = 202 y = 1.02x + 2.6 r = 0.989 range = 51 to 490 mg/dL |
| Trained HCP vs. Reference (Venous Blood) | Correlation (r) > 0.990, Slope (y) approx. 1.05x-1.0x, Intercept (b) approx. -0.6 (based on predicate) | N = 104 y = 1.029x + 2.7 r = 0.995 range = 35 to 483 mg/dL |
| Consumers vs. Reference | Comparable performance to trained health care professionals, supporting OTC use. (Predicate did not perform this study, relying on existing data for its glucose oxidase strips) | N = 134 y = 1.082x - 2.9 r = 0.976 range = 58 to 357 mg/dL |
| Precision | (Implicitly similar or better than predicate, and low standard deviation) | |
| Control Level 1 (Mean ± SD) | Approx. 42.0 ± 4.2 mg/dL (based on predicate) | Mean: 84.0 mg/dL SD: 2.0 |
| Control Level 2 (Mean ± SD) | Approx. 104.0 ± 3.0 mg/dL (based on predicate) | Mean: 196.4 mg/dL SD: 2.5 |
| Venous Blood Level 1 (Mean ± SD) | Approx. 53.0 ± 3.9 mg/dL (based on predicate) | Mean: 28.7 mg/dL SD: 1.2 |
| Venous Blood Level 2 (Mean ± SD) | Not applicable for predicate | Mean: 87.3 mg/dL SD: 2.6 |
| Venous Blood Level 3 (Mean ± SD) | Not applicable for predicate | Mean: 129.4 mg/dL SD: 3.0 |
| Venous Blood Level 4 (Mean ± SD) | Approx. 233.0 ± 2.9 mg/dL (based on predicate) | Mean: 229.2 mg/dL SD: 2.8 |
| Venous Blood Level 5 (Mean ± SD) | Approx. 490.0 ± 3.6 mg/dL (based on predicate) | Mean: 335.0 mg/dL SD: 3.4 |
2. Sample Size Used for the Test Set and Data Provenance
- Trained health care professional versus reference (Capillary blood): N = 202
- Trained health care professional versus reference (Venous blood): N = 104
- Consumers versus reference: N = 134
- Precision (Control levels): N = 20/Level (for 2 levels)
- Precision (Venous Blood levels): N refers to the samples run for precision, but the exact number for blood levels isn't explicitly stated as "N = X" in the same way as controls, only mean and SD are provided per level. However, precision studies typically involve multiple replicates.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, given the context of a 510(k) submission, these would typically be prospective studies conducted in a clinical or laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth. The "reference" is mentioned, which implies a laboratory reference method (e.g., a YSI analyzer), not human expert consensus, for determining blood glucose levels. The "Trained health care professional" refers to the user of the device, not an expert establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable. Blood glucose measurements typically use a reference laboratory method as the ground truth, not human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, this type of study was not conducted as this is a blood glucose monitoring device, not an imaging device requiring human interpretation. The study involved comparison of the device's readings against a reference method, with different types of users (trained healthcare professionals, consumers).
6. Standalone (Algorithm Only) Performance
Yes, the accuracy and precision studies described represent standalone performance of the device without human-in-the-loop assistance influencing the measurement itself. The human interaction is limited to operating the device (e.g., applying the blood sample) in the intended use case (self-monitoring or healthcare professional use).
7. Type of Ground Truth Used
The ground truth used was a reference method (implied to be a laboratory standard for blood glucose measurement). This is evident from phrases like "Trained health care professional versus reference" and "Consumers versus reference."
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" for an algorithm. This is a medical device, and the performance data presented are for validation/testing, not for training a machine learning model. If any calibration or development was done using data, it is not detailed here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a discrete "training set" in the context of an algorithm's development is not discussed in this device's 510(k) summary.
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OCT - 9 1997
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 | Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000 |
|---|---|
| Contact Person: Mike Flis | |
| Date Prepared: August 01, 1997 | |
| 2) Device name | Proprietary name: Glucotrend TM Basic System |
| Common name: self-monitoring blood glucose test system | |
| Classification name: Blood glucose test | |
| 3) Predicate device | We claim substantial equivalence to the Boehringer Mannheim Accu-Chek Advantage System with the Advantage H Test Strip. |
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510(k) Summary
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| 4) DeviceDescription | Instrument Operating Principle -- photometricReagent Test Principle -- glucose deoxy reductase | ||
|---|---|---|---|
| 5) Intended use | The Glucotrend Basic System is designed for testing glucose by persons withdiabetes or by health care professionals in the home or in health care facilities | ||
| 6) Comparisonto predicatedevice | The Boehringer Mannheim Glucotrend Basic System is substantiallyequivalent to other products in commercial distribution intended for similaruse. Most notably it is substantially equivalent to the currently marketedBoehringer Mannheim Accu-Chek Advantage System with the Advantage HTest Strip. | ||
| Similarities toPredicateDevice | - Intended use (blood glucose monitoring) | ||
| - Closed system (instrument and reagents are provided by BMC and areintended to only be used in conjunction with each other) | |||
| - Glucose dehydrogenase test principle | |||
| - Verified reportable range (10 to 600 mg/dL) | |||
| - Test strip packaging (desiccated vials with multiple strips) | |||
| - Test strip storage conditions | |||
| - Recommended quality control testing procedure | |||
| - Specimen collection and preparation instructions | |||
| - Monitor requires no scheduled maintenance other than cleaning | |||
| - Instructions regarding response to unusual results | |||
| - Warnings and precautions | |||
| - Results referenced to whole blood laboratory testing |
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Differences
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| Feature | Accu-Chek AdvantageSystem with theAdvantage H TestStrip (predicate) | Glucotrend Basic(new device) |
|---|---|---|
| Instrument operatingprinciple | amperometric | photometric |
| Blood sample types | capillary, venous,arterial, and neonate | capillary and venous |
| Minimum samplevolume | 9 µL | 3 µL |
| Operating temperaturerange | 14°C to 40°C | 10°C to 40°C |
| Hematocrit range | 20-65% at <200 mg/dL25-55% at >200 mg/dL | 30-57% |
| Maximum altitudeverified | 10,150 feet | 9500 feet |
| Visual result back-up | None | Blank + 5 color blockson strip canister |
| Interferences | Low concentration:· XyloseHigh concentration:• Uric Acid· Galactose· Lipemic sample >5000 mg/dL | Low concentration:· XyloseHigh concentration:• Uric Acid· Galactose |
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Performance
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Characteristics
Accuracy
| Parameter | Accu-Chek AdvantageSystem with theAdvantage H TestStrip (predicate) | Glucotrend Basic(new device) |
|---|---|---|
| Trained health careprofessional versusreference(Capillary blood) | N = 166y = 0.99x + 5.0r = 0.973range = 43 to 478 mg/dL | N = 202y = 1.02x + 2.6r = 0.989range = 51 to 490 mg/dL |
| Trained health careprofessional versusreference(Venous blood) | N = 166y = 1.05X - 0.6r = 0.990range = 40 to 457 mg/dL | N = 104y = 1.029 x + 2.7r = 0.995range = 35 to 483 mg/dL |
| Arterial blood study | N = 206y = 1.06x - 3.5r = 0.973 | not applicable |
| Neonate blood study | N = 303y = 0.98x + 2.81r = 0.94range = 20 to 305 mg/dLhematocrit range = 26 to69% | not applicable |
| Consumers versusreference | Not performed--claimdata from glucose oxidasetest strip supports OTCuse | N = 134y = 1.082x - 2.9r = 0.976range = 58 to 357 mg/dL |
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Performance
Characteristics,
Contd.
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Precision
| Parameter | Accu-Chek AdvantageSystem with theAdvantage H TestStrip (predicate) | Glucotrend Basic(new device) |
|---|---|---|
| N = 96/Level (Control)N = 60/Level (Blood) | N = 20/Level | |
| Control Level 1•Mean (mg/dL) | 42.0 | 84.0 |
| •Standard Deviation (SD) | 4.2 | 2.0 |
| Control Level 2•Mean (mg/dL) | 104.0 | 196.4 |
| •Standard Deviation (SD) | 3.0 | 2.5 |
| Venous Blood Level 1•Mean (mg/dL) | 53.0 | 28.7 |
| •Standard Deviation (SD) | 3.9 | 1.2 |
| Venous Blood Level 2•Mean (mg/dL) | not applicable | 87.3 |
| •Standard Deviation (SD) | 2.6 | |
| Venous Blood Level 3•Mean (mg/dL) | not applicable | 129.4 |
| •Standard Deviation (SD) | 3.0 | |
| Venous Blood Level 4•Mean (mg/dL) | 233.0 | 229.2 |
| •Standard Deviation (SD) | 2.9 | 2.8 |
| Venous Blood Level 5•Mean (mg/dL) | 490.0 | 335.0 |
| •Standard Deviation (SD) | 3.6 | 3.4 |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 9 1997
Mr. Mike Flis Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250
Re : K972876 Glucotrend™ Basic System Trade Name: Requlatory Class: II Product Code: LFR Dated: July 31, 1997 Received: August 4, 1997
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 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 requirement, 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/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: Glucotrend Basic System
Indications for Use:
The Glucotrend Basic System is designed for testing glucose by persons with diabetes or by health care professionals in the home or in health care facilities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboras vices
510(k) Number K972876
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§ 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.