(966 days)
Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick.
Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician.
Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant.
This test can not be used to screen or diagnose diabetes.
It should not be used for children or by individuals who are diabetic or pregnant.
This test is only intended for individual use at home.
It is not for use as part of a screening program in a healthcare setting or any other setting.
Reagent test principle - glucose oxidase
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) premarket notification summary for the Betachek Blood Glucose Test, primarily focusing on establishing substantial equivalence to a predicate device.
While it mentions "Performance Characteristics" and "clinical evaluations," it does not provide the specific numerical acceptance criteria for performance metrics (like accuracy or precision) nor the detailed results of a study to demonstrate these. The document states, "Betachek Blood Glucose Test has the same intended use and technological characteristics as the predicate device and clinical evaluations demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This general statement of equivalence is not a report of specific performance criteria and study results.
Therefore, many of the requested fields cannot be filled. However, based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Test Range: 50 mg/dL - 150 mg/dL (Implied acceptance based on predicate) | Betachek Blood Glucose Test: 50 mg/dL - 150 mg/dL |
| Test Time: 3 minutes (Implied acceptance based on predicate) | Betachek Blood Glucose Test: 3 minutes |
Explanation: The document states the Betachek Blood Glucose Test has the "same intended use and technological characteristics" as the predicate. The operational parameters like Test Range and Test Time are listed as identical to the predicate, implying these are the "performance" that matched the "acceptance criteria" (which would be meeting the predicate's performance). However, explicit numerical accuracy, precision, or other performance acceptance criteria are not provided, nor are specific study results for these metrics.
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.
- Data Provenance: Not specified. The document mentions "clinical evaluations" but gives no details about where, when, or how these were conducted.
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 applicable/Not specified. The device is a "Glucose Test System" for a finger-stick blood sample, which typically relies on a chemical reaction for the result, not expert interpretation of images or other subjective data requiring ground truth established by experts in that manner. Any reference method used for comparison would be a laboratory instrument.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, for the same reason as point 3.
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 is a blood glucose test, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a self-use, non-instrumented test strip. The "performance" is the result obtained directly from the chemical reaction on the strip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but for a blood glucose test, the "ground truth" (or reference method) would typically be quantitative laboratory reference methods as hinted at in the Intended Use: "Any abnormal results should be verified by a medical professional... and confirmed with a quantitative, laboratory reference method."
8. The sample size for the training set
- Not applicable. This device is not described as utilizing machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set described.
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According to the requirements of 21 CFR 807.92, the following information a) provides sufficient detail to understand the basis for a determination of substantial equivalence.
-
- Submitter's Name:
National Diagnostic Products (Aust) Pty Ltd
- Submitter's Name:
Address:
| Phone: | |
|---|---|
| Fax: | |
| Contact Person: | |
| Date Prepared: |
22/39 Herbert Street. St.Leonards NSW 2065, Australia +61 2 94328100 +61 2 94361151 Brandon Bransgrove March 24, 2009
-
- Device Name: Proprietary/Trade name: Common Name: Classification Name: Device Classification: Requlation Number: Classification Panel: Product Code:
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- Predicate Device Name: Manufacturer: 510 (K) Number:
Glucose Test System 21 CFR 862.1345 Clinical Chemistry (75) CGA (Glucose Oxidase, Glucose)
Betachek Blood Glucose Test
Betachek Blood Glucose Test
Glucose Test System
Chemcard Glucose Test CHEM-ELEC, INC K943503
- Description of the Device Reagent test principle - glucose oxidase
5. Intended Use
Betachek Blood Glucose Test is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick.
Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician.
Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant.
This test can not be used to screen or diagnose diabetes. It should not be used for children or bv individuals who are diabetic or preqnant. This test is only intended for individual use at home.
It is not for use as part of a screening program in a healthcare setting or any other setting.
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| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Betachek BloodGlucose Test | Chemcard Glucose Test | |
| Detection Method | Enzyme linked colourchange | Enzyme linked colourchange |
| Sample | Finger stick blood sample | Finger stick blood sample |
| Sample Volume | 1 drop (no samplepremeasurement) | 1 drop (no samplepremeasurement) |
| Enzyme 1 | Glucose Oxidase(Aspergillus niger) | Glucose Oxidase(Aspergillus niger) |
| Enzyme 2 | Peroxidase | Peroxidase |
| Dye | TMB, APAC, DCP | TMB |
| Instrument required | No | No |
| Intended use | a test intended to be usedby non-diabetic individualsat home to estimate theirfasting blood glucose(blood sugar) level from adrop of blood obtainedfrom a finger stick. | a semi-quantitative glucosetest intended to be used bya person who has not beendiagnosed as diabetic tomeasure his or her fastingglucose level in order todetermine whether thefasting glucose level isabnormal |
| Operating Temperature | 18 - 35° C | 18 – 35° C |
| Test Range | 50 mg/dL - 150 mg/dL | 50 mg/dL - 150 mg/dL |
| Test Time | 3 minute | 3 minutes |
| Number of colour blocks | 5 | 5 |
| Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Betachek BloodGlucose Test | Chemcard Glucose Test | |
| Format | Test strip | Test Card |
| User steps | Blood wiped at 1 minuteand result read after3minutes. | Card Peeled at 3 minutesand result must read within30 seconds. |
| Hematocrit Range | 35% - 55% | Unknown |
7. Performance Characteristics
Betachek Blood Glucose Test has the same intended use and technological characteristics as the predicate device and clinical evaluations demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Therefore, Betachek Blood Glucose Test is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
National Diagnostic Products c/o Mr. Brandon Bransgrove 7-9 Merriwa Street, Gordon Sydney, NSW, 2072 Australia
MAR 2 4 2009
Re: K062187
Trade Name: Betachek Blood Glucose (Sugar) test Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: December 22, 2008 Received: December 24, 2008
Dear Mr. Bransgrove:
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 (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.
Cary C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
K062187 · · · 510(k) Number:
BETACHEK BLOOD GLUCOSE (SUGAR) TEST Device Name:
Indication For Use:
Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick.
Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician.
Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant.
This test can not be used to screen or diagnose diabetes.
It should not be used for children or by individuals who are diabetic or pregnant.
This test is only intended for individual use at home.
It is not for use as part of a screening program in a healthcare setting or any other setting.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or
V Over the Counter Use (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)
signature
Division Sign-Off Øffice of In Vitro Diagnostic Device Evaluation and Safety
510(k) K062187
§ 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.