(522 days)
Not Found
No
The document describes a standard electrochemical biosensor technology for glucose measurement and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a condition or disease.
Yes
The device is explicitly stated as an "in vitro diagnostic use only" system intended to aid in monitoring the effectiveness of diabetes control, which falls under the definition of a diagnostic device.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, control solutions, and a lancing device, all of which are hardware components. While the meter likely contains software, the system is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states: "The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only)..."
This directly identifies the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.
The system consists of the microdot® Home Blood Glucose meter, microdot® Home Test Strips and microdot® Control solutions.
microdot® Home Test Strips
The microdot® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone.
microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only.
microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingerstick or palm
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
self testing outside the body (in vitro diagnostic use only), by people with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison Studies
Alternate Site Testing at Palm
A consumer study was performed with 152 diabetics testing themselves both at finger and alternate site and healthcare professionals testing at finger only to see if the results obtained at the alternate site is comparable with the finger. The diabetics obtained the samples and carried out the tests using the instructions provided. The samples ranged from 48 to 367 mg/dL. The palm results were comparable to finger results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Summary of Accuracy Results for all sites tested
For glucose levels
§ 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.
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510(k) Summary
K102383
Purpose for Submission: Addition of Palm testing (alternate site) to existing product.
Analyte: Whole blood Glucose
Type of Test: Quantitative (electrochemical biosensor)
Applicant: Cambridge Sensors.Limited
Units 9 & 10 Cardinal Park Godmanchester Huntingdon Cambs PE29 2XG United Kingdom
Contact Name: Dr. Bernadette Yon-Hin
Date: 24th January 2012
Proprietary and names:
microdot® Home Blood Glucose Monitoring system : microdor® Home Blood Glucose Meter
microdot® Home Test Strips consisting of three products
microdot® Control solutions
Regulatory Information:
Regulation section: 21 CFR § 862.1345, Blood Glucose Test System
Classification: Class II, Class I
Product Code: NBW, Blood Glucose test system, over the counter LFR, Glucose Dehydrogenase, glucose
Panel: Clinical chemistry (75)
Intended Use
Intended use(s): See indication(s) for use below
Cambridge Sensors Limited
1
Indication(s) for use:
The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.
The system consists of the microdot Home Blood Glucose meter, microdot 8 Home Test Strips and microdot® Control solutions.
microdot® Home Test Strips
The microdot 8 Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.
Special conditions for use statements(s):
This product is intended for over-the-counter. Fingerstick testing only (no palm testing) should be performed if blood glucose level is changing rapidly as follows:
- Within 2 hours after a meal ◆
- Within 2 hours after insulin dosing .
- Patients with a history of hypoglycaemia, experiencing symptoms of low sugar or suffer from hypoglycaemic unawareness.
Special instrument requirements:
microdot® Home Blood Glucose Meter
Device Description:
The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone.
microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only.
microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative
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510(k) Summary
electrochemical biosensor technology to measure current generated on disposable test strips.
The strip remains unchanged since the last submission approval, microdot® Xtra Blood Glucose Monitoring System (K083273). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes.
Substantial Equivalence Information:
Predicate device name (s):
microdot® Blood Glucose Monitoring System, 510(k) Number :K070524
microdot® Xtra Blood Glucose Monitoring System, 510(k) Number:K083273 Comparison with predicate:
microdot® Home Test Strips share the same design, functionality, raw materials and manufacturing process as. microdof® Xtra Test Strips.
| Device 1 | Predicate 1 | Predicate 2 | |
|---|---|---|---|
| Product Name | microdot® Home | microdot® | |
| (K070524) | microdot® Xtra | ||
| (K083273) | |||
| Code | No code number | Code Number for | |
| each lot of strips | No code number | ||
| Enzyme | Glucose | ||
| Dehydrogenase/NAD | Same | Same | |
| Sample | Fresh Capillary whole | ||
| blood | Same | Same | |
| Blood Source | Finger, Palm | Finger | Finger |
| Test Principle | Electrochemical Biosensor | Same | Same |
| Calibration | Plasma equivalent | Same | Same |
| Sample volume | 600nanoliters | Same | Same |
| Temperature and | |||
| humidity range | 10°- 40°C | ||
| 10-90% RH | Same | Same | |
| Hematocrit range | 30-50% | Same | Same |
| Measurement | |||
| Range | 25 - 525 mg/dL | Same | Same |
| Control Solution | Low, Normal, High | Same | Same |
Comparison to Predicate Devices:
Standard/Guidance Document referenced (if applicable):
ISO15197:2003: in vitro diagnostic test systems- requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus (Section 8: User Performance)
Test Principle
Cambridge Sensors Limited
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510(k) Summary
The test is based on the enzymatic conversion of glucose in the sample to gluconolactone, with concomitant reduction of the enzyme cofactor NAD* to NADH. The NADH is re-oxidised to NAD* by the mediator compound which in turn becomes reduced; re-oxidation of the mediator by the meter induces a micro current to flow, and the size of this micro current is directly proportional to the amount of glucose in the sample. Unlike PQQ dependent Glucose Dehydrogenase, the NAD-dependent Glucose Dehydrogenase enzyme used in the microdor® Home test strips is specific to glucose and has no interference from galactose and maltose.
Performance Characteristics
- Analytical Performance
Precision/ Reproducibility Established in original submission (K070524)
Linearity/assay reportable range Established in original submission (K070524)
Traceability, Stability', Expected values (controls, calibrators, or methods) Established in original submission (K070524)
Detection Limit Established in original submission (K070524)
Analytical Specificity · Established in original submission (K070524)
Assay Cut-off Not applicable
- Comparison Studies
Comparison with predicate device Established in original submission (K070524)
Alternate Site Testing at Palm
A consumer study was performed with 152 diabetics testing themselves both at finger and alternate site and healthcare professionals testing at finger only to see if the results obtained at the alternate site is comparable with the finger. The diabetics obtained the samples and carried out the tests using the instructions provided. The samples ranged from 48 to 367 mg/dL. The palm results were comparable to finger results.
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| Summary of Accuracy Results for all sites tested | |||
|---|---|---|---|
| Sites tested | For glucose levels |