DS-A BLOOD GLUCOSE MONITORING SYSTEM
Device Facts
| Record ID | K082965 |
|---|---|
| Device Name | DS-A BLOOD GLUCOSE MONITORING SYSTEM |
| Applicant | Alliance International Co., Ltd. |
| Product Code | CGA · Clinical Chemistry |
| Decision Date | Dec 7, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for neonates. The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Device Story
System measures glucose in fresh capillary whole blood via fingerstick; utilizes DS-A test strips and meter. Principle: glucose oxidase (GOD) electrochemical biosensor; electrons released during reaction generate current proportional to glucose concentration. Meter converts electronic signal to concentration; displays result. User inserts lot-specific calibration card into meter to set coefficients. Used by patients (home) or professionals (clinic). Output: quantitative blood glucose concentration. Benefits: aids diabetes management. System includes meter, test strips, lancets, and control solutions for accuracy verification.
Clinical Evidence
Clinical study with 150 lay users at three physician office laboratories; subjects performed self-testing using labeling. Results compared to YSI 2300 reference. Accuracy met ISO 15197:2003 standards: 100% of results within ±15 mg/dL (for <75 mg/dL) and 100% within ±20% (for ≥75 mg/dL). Regression: y=0.954x + 0.3382, r²=0.996. Ease-of-use survey showed high user comprehension (scores 4.34-4.89/5).
Technological Characteristics
Electrochemical biosensor with carbon electrodes; glucose oxidase (GOD) enzyme. Meter weight 56g. Coding via code card. Measurement range 20-600 mg/dL. Connectivity: 360 test result memory. Operates on capillary whole blood.
Indications for Use
Indicated for persons with diabetes (home/OTC) or clinical settings for monitoring blood glucose effectiveness. Not for neonates, diagnosis/screening of diabetes, alternative site testing, or critically ill/dehydrated/shock patients.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Roche Accu-Chek Aviva System (k043474)
Related Devices
- K062892 — EUKARE · Eumed Biotechnology Co., Ltd. · Jan 22, 2007
- K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM · Hmd Biomedical, Inc. · Nov 9, 2012
- K100322 — TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277 · Taidoc Technology Corporation · Jun 28, 2010
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k082965
B. Purpose for Submission:
New device
C. Measurand:
Whole blood glucose
D. Type of Test:
Quantitative glucose oxidase
E. Applicant:
Alliance International Co., Ltd
F. Proprietary and Established Names:
DS-A Blood Glucose Monitoring System
G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1345, Glucose
21 CFR § 862.1660, Quality Control Material, assay and unassayed
2. Classification:
Class II, Class I, reserved
3. Product code:
CGA—Glucose oxidase, Glucose
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NBW—System, Test, Blood Glucose, Over the Counter
JJX—Single (specified) analyte controls (assayed and unassayed)
4. Panel:
Chemistry (75)
H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
The A-CHECK DS-A Blood Glucose Monitoring System is used with DS-A Test Strips and 3-level Controls for the measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The DS-A Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. DS-A Test Strips must be used with the A-CHECK DS-A Blood Glucose Monitoring System. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.
The Alliance Blood Glucose 3 levels Control Solution are for use with the A-CHECK DS-A Blood Glucose Monitoring System and DS-A Test Strips as a quality control check to verify the accuracy of blood glucose test results.
3. Special conditions for use statement(s):
Over the Counter (OTC)
Not for diagnosis of or screening for diabetes mellitus
Not for use on neonates
Not for use for alternative site testing
Not for use in critically ill, dehydrated or hyperosmolar patients or patients in shock
4. Special instrument requirements:
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DS-A Blood Glucose Meter
I. Device Description:
The DS-A Blood Glucose Monitoring System consists of the DS-A Blood Glucose meter and the DS-A Draw-In Blood Glucose Test Strips. The start-up kit includes the DS-A Blood Glucose Meter with battery, lancet device and 10 lancets, DS-A Draw-In Glucose Test Strips with code card, User's Manual, Quick Reference Guide, Diary for Self-Monitoring and a mid-level Quality Control solution.
Alliance Blood Glucose Control Solutions are three levels of controls which are used for performance checks on the Draw-In Blood Glucose Test Strips and are purchased separately.
J. Substantial Equivalence Information:
1. Predicate device name(s):
Roche Accu-Chek Aviva System
2. Predicate 510(k) number(s):
k043474
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Items | A-CHECK DS-A
(Alliance International)
Subject Device | Accu-Chek Aviva (Roche)
Predicate Device (k043474) |
| Intend Use | The A-CHECK DS-A Blood Glucose Monitoring System is used with the A-CHECK DS-A Draw-In Blood Glucose Test Strips and 3-level Controls for the measurement of glucose in whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over-the-counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes. | The ACCU-CHEK Aviva system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring blood glucose in the home or health care facility. The device is intended for professional use and over-the-counter sale. Professionals may use the test strip to test capillary and venous blood samples; lay use is limited to capillary whole blood testing. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf. |
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| Meter Dimension | 94.5mm x 56mm x 27.5mm | 94mm x 53mm x 22.86mm |
| --- | --- | --- |
| Sample Volume | 1 uL | 0.6uL |
| Measuring Time | 6 seconds | 5 seconds |
| Detecting Range | 20 ~ 600 mg/dL | 10~ 600 mg/dL |
| HCT Range | 30 ~ 55 mg/dL | 20-70 mg/dL |
| Battery Power | One 3V Lithium CR 2032 battery | One 3V lithium coin cell battery |
| Meter Check | Resistor (Code Card) | Resistor (Code Key) |
| Data Recall | By button | By button |
| Button Design | Two buttons | Two buttons |
| Strip Dimension | 35mm x 7mm x 0.35mm | 37mm x 9mm x 0.35mm |
| Differences | | |
| --- | --- | --- |
| Items | A-CHECK DS-A (Alliance International) Subject Device (k082965) | Accu-Chek Aviva (Roche) Predicate Device (k043474) |
| Test Principle | GOD Electrochemical biosensor with carbon electrodes | GDH Electrochemical |
| Meter Weight | 56 g | 60 g |
| Memory Storage | 360 test results | 500 blood glucose results |
| Meter Coding | Code Card | Code Key |
| Operating Temperature | 14 to 40 °C | 6 to 44 °C |
| Strip Storage Temperature | 4 to 32 °C | 2 to 32 °C |
| Limitations | Not for use with venous serum or plasma samples. | For use with venous serum or plasma or capillary whole blood |
# K. Standard/Guidance Document Referenced (if applicable):
CLSI EP 7A2: Interference Testing in Clinical Chemistry
ISO 15197:2003, In Vitro Diagnostic Test Systems—Requirements for Blood Glucose Test Systems for Self Managing Diabetes Mellitus.
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IEC/EN 61010-1, Medical electrical equipment Part 1. General requirements for safety, 2001.
## L. Test Principle:
The DS-A Draw-In Blood Glucose Test Strips use the reaction of glucose oxidase (GOD) with capillary whole blood glucose to form gluconic acid. This, in turn reacts with potassium ferricyanide on the strips to form ferricyanide. During this reaction, electrons are released which generate a current proportional to the concentration of glucose present in the sample.
The DS-A Blood Glucose Meter uses amperometric biosensor technology to convert the electronic signal to concentration which is displayed on the meter. The meter is calibrated by inserting a lot specific calibration strip into the meter prior to starting a new box of test strips. This is provided in each box of test strips.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Repeatability studies were conducted using venous blood samples with target concentrations of 40 mg/dL, 80 mg/dL, 120 mg/dL 200 mg/dL and 300 mg/dL. Concentrations were confirmed on the Yellow Springs analyzer (YSI). Within-run precision was determined by analyzing each sample 40 times on each of 3 lots of strips. The summary of all lots is below
Within-run Precision (Repeatability)
| 40 mg/dL | | | | 80 mg/dL | | | 120 mg/dL | | | 200 mg/dL | | | 300 mg/dL | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Mean | 41 | 42 | 42 | 86 | 92 | 87 | 132 | 128 | 140 | 209 | 212 | 211 | 323 | 330 | 332 |
| SD | 2.5 | 2.5 | 2.6 | 3.8 | 3.6 | 4.2 | 6.4 | 5.5 | 4.0 | 4.7 | 5.2 | 4.9 | 7.0 | 8.1 | 9.1 |
| %CV | 6.1 | 5.7 | 6.2 | 4.4 | 3.9 | 4.8 | 4.8 | 4.3 | 2.8 | 2.3 | 2.4 | 2.3 | 2.2 | 2.4 | 2.7 |
Day-to-day precision studies were conducted using quality control material at 3 levels, 50 mg/dL, 120 mg/dL and 340 mg/dL, three lots of test strips and 12 meters. The testing was performed for 10 days and consisted of four replicates per day per strip lot. Control values were verified with the YSI Glucose Analyzer.
| | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AVG. (mg/dL) | 53 | 53 | 52 | 135 | 134 | 136 | 340 | 340 | 340 |
| S.D. (mg/dL) | 2.3 | 2.1 | 2.2 | 5.7 | 4.6 | 5.4 | 11.5 | 10.8 | 13.9 |
| C.V.% | 4.3% | 3.9% | 4.2% | 4.2% | 3.4% | 4.0% | 3.4% | 3.2% | 4.1% |
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# b. Linearity/assay reportable range:
Five venous whole blood samples were spiked with glucose to cover the measuring range of $20 - 600\mathrm{mg / dL}$ , and evaluated 20 times per sample on the DSA Blood Glucose meter and the YSI analyzer. Values ranged from $21 - 590\mathrm{mg / dL}$ . Each sample was analyzed on 5 A-Check DS-A meters with 2 lots of test strips. Linear regressions for each strip lot compared to the YSI are below:
| Lot | Slope | Intercept | r | R2 |
| --- | --- | --- | --- | --- |
| 1 | 1.02 | -2.1 mg/dL | 0.996 | 0.993 |
| 2 | 1.01 | 2.5 mg/dL | 0.997 | 0.994 |
# c. Traceability, Stability, Expected values (controls, calibrators, or methods):
There are three levels of Quality Control material available for separate purchase. They cover the low, middle and high glucose range. The mid-range control is included with each test kit.
# Traceability
1) Traceability: The DS-A-CHECK meter is compared to the YSI 2300 Glucose Analyzer in the accuracy studies below. The YSI is calibrated with NIST (SRM) 917a reference material. Quality control material is gravimetrically prepared and assayed on the DS-A-Check meters in multiple runs to establish ranges. Control ranges are included on each vial of test strips.
# Stability
1) Accelerated and real-time temperature and humidity studies for the DS-A Draw-In Test Strips were conducted to determine closed and open vial test strip stability and to verify performance of the meter and strips at temperatures of $0^{\circ}\mathrm{C} - 40^{\circ}\mathrm{C}$ . Real time studies were conducted for 19 months. Closed vial stability is 18 months at $24^{\circ}\mathrm{C} \pm 3^{\circ}\mathrm{C}$ and $60\% \pm 10\%$ relative humidity. Open vial strip stability is 90 days at $4 - 32^{\circ}\mathrm{C}$ at $80\%$ relative humidity. Recommended operating temperatures are $14^{\circ}\mathrm{C} - 40^{\circ}\mathrm{C}$ .
2) Alliance Blood Glucose Control Solutions stability studies were conducted in real time. Closed vial stability at $23^{\circ}\mathrm{C}$ to $27^{\circ}\mathrm{C}$ is 18 months. Open vial stability studies were performed at $20^{\circ}\mathrm{C}, 25^{\circ}\mathrm{C}$ and $30^{\circ}\mathrm{C}$ . Open vial stability for $20^{\circ}\mathrm{C}-30^{\circ}\mathrm{C}$ is 90 days.
# Calibration
The meter is factory calibrated but each vial of test strips has a calibration card containing the calibration coefficients for each lot of test strips. The Operator's Manual instructs the user to load the calibration card for each test vial prior to using
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the strips in a new vial. The lot number displayed on the meter after loading the calibration card must match the lot number on the strip vial. If there is no match, an error message is generated and no glucose result is displayed.
d. Detection limit:
The detection limit is 20 mg/dL as described is section M.1.b. above.
e. Analytical specificity:
Endogenous and Exogenous Interference
Endogenous and exogenous substances were analyzed at two concentrations of glucose and interferent according to CLSI EP 7. Each concentration of interferent was added to whole blood samples whose glucose concentrations had been adjusted to between 100-150 mg/dL, and 200-250 mg/dL as measured on the YSI 2300 analyzer. The sponsor defined no significant interference as less than 10% interference when compared to the control pools with no interferents added. Results are summarized below.
Summary of Interferences
| # | Substance | Exogenous Substance | | | Elevated Challenge | Significant Interference Pos/Neg |
| --- | --- | --- | --- | --- | --- | --- |
| | | Therapeutic Concentration | Test Concentration (Low) | Significant Interference Yes/No | | |
| 1 | Acetaminophen | 1-2 mg/dL | 2mg/dL | no | 20mg/dL | no |
| 2 | Ascorbic Acid | 0.8 - 1.2 mg/dL | 1.2mg/dL | yes | 3mg/dL | yes |
| 3 | Dopamine | N.A. | 1.25 mg/dL | yes | 30mg/dL | yes |
| 4 | Ibuprofen | 0.5 - 4.2 mg/dL | 4.4mg/dL | no | 40mg/dL | no |
| 5 | L-Dopa | N.A. | 10mg/dL | yes | 20 mg/dL | yes |
| 6 | Tetracycline | 0.4 mg/dL | 0.4mg/dL | no | 0.4mg/dL | no |
| 7 | Tolbutamide | 5.3 - 10 mg/dL | 10mg/dL | no | 100mg/dL | no |
| # | Substance | Endogenous Substance | | | Elevated Challenge | Significant Interference Yes/No |
| --- | --- | --- | --- | --- | --- | --- |
| | | Normal Concentration | Test Concentration (Low) | Significant Interference Yes/No | | |
| 1 | Cholesterol | 250 mg/dL | 250mg/dL | no | 500mg/dL | no |
| 2 | Creatinine | 1.5 mg/dL | 1.5mg/dL | no | 30mg/dL | no |
| 3 | Uric Acid | 7 mg/dL | 7mg/dL | yes | 20mg/dL | yes |
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# Hematocrit
Six whole blood samples with hematocrits ranging from 30% - 55% were tested at four different glucose concentrations of approximately 50 mg/dL to 500 mg/dL against the YSI. The percent differences of the DS-A glucose results at each hematocrit level were calculated against the YSI glucose results at 40% hematocrit. The sponsor demonstrated that for each level of hematocrit there was ≤ 12% difference across the entire glucose range. A caution about using samples with < 30% or > 55% is stated in the labeling.
# Altitude Studies
Altitude studies were performed using five whole blood samples with glucose concentrations from 52-498 mg/dL as determined on the YSI 2300. Each sample was tested in duplicate on six meters and 1 lot of test strips at 6 altitudes. Values were compared to the YSI 2300 (see chart below). The sponsor demonstrated a <16% CV for all samples across all lots on the DS-A-CHECK for glucose concentrations between Sea level.- 8,563 ft. Summarized results are below:
| YSI | 52 mg/dL | 121 mg/dL | 202 mg/dL | 354 mg/dL | 498 mg/dL |
| --- | --- | --- | --- | --- | --- |
| Test Altitudes/Test Conc. | 50mg/dL | 120mg/dL | 200mg/dL | 350mg/dL | 500mg/dL |
| --- | --- | --- | --- | --- | --- |
| Sea Level | 57 | 127 | 207 | 360 | 507 |
| 775 meters/2542.6 ft. | 57 | 125 | 208 | 362 | 506 |
| 1460 meters/4790 ft. | 57 | 126 | 209 | 363 | 508 |
| 1900 meters/6528.8 ft. | 56 | 126 | 208 | 361 | 509 |
| 2310 meters/7578.7 ft. | 56 | 125 | 209 | 362 | 506 |
| 2610 meters/8562.9 ft. | 49 | 120 | 200 | 350 | 499 |
| Mean | 55 | 125 | 207 | 360 | 506 |
| SD | 2.87 | 2.27 | 3.13 | 4.42 | 3.24 |
| CV% | 5.2% | 1.8% | 1.5% | 1.2% | 0.6% |
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f. Assay cut-off:
Not applicable
## 2. Comparison studies:
a. Method comparison with predicate device:
178 capillary whole blood samples were collected from test subjects and analyzed in singlicate by a laboratory professional and were analyzed on the DS-A Check meter and the YSI 2300. To obtain the very high and very low levels, 8 samples were collected immediately after the individual finished a meal and 8 samples were stored overnight. Glucose concentrations ranged from 31-541 mg/dL.
Regression for the DS-A glucose system and the YSI was y=1.0032x + 4.5469, r²=0.9938. The study met the ISO 15197 standard where ninety-five percent (95%) of the individual glucose results fall within ±15mg/dL of the reference results at glucose concentrations <75mg/dL and within ±20% at glucose concentrations ≥75mg/dL. The data summary for capillary samples tested by professionals is shown below:
Accuracy for glucose < 75 mg/dL
| Within ± 5 mg/dL | Within ± 10/mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 16/32 (50.0%) | 25/32 (78.1%) | 32/32 (100%) |
Accuracy for glucose ≥ 75 mg/dL
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| --- | --- | --- | --- |
| 102/146 (69.9%) | 124/146 (84.9%) | 136/146 (93.2%) | 146/146 (100.0%) |
b. Matrix comparison:
Not applicable. The device is for capillary fingerstick only.
## 3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
A 150 sample lay user study of English speaking subjects was conducted at three
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Physician's Office Laboratories (POL). Each lay user read the User's Guide in English and collected and tested a fingerstick sample on themselves. A laboratory professional also collected a fingerstick from the subjects to analyze on the YSI and a venous blood sample to check the hematocrit levels. Fingerstick samples ranged from 49-424 mg/dL. Hematocrits ranged from 35-55 %. Three lots of test strips and one meter was used by the lay users. The regression for the lay user results compared to the YSI was y=0.954x + 0.3382, r² = 0.996. The study met the ISO 15197 standard where ninety-five percent (95%) of the individual glucose results shall fall within ±15mg/dL of the reference results at glucose concentrations <75mg/dL and within ±20% at glucose concentrations ≥75mg/dL. The breakdown of lay user results following ISO 15197 is shown below:
Accuracy for glucose < 75 mg/dL
| Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL |
| --- | --- | --- |
| 15/18 (83.3%) | 18/18 (100%) | 18/18 (100%) |
Accuracy for glucose ≥ 75 mg/dL
| Within ± 5% | Within ± 10 % | Within ± 15 % | Within ± 20 % |
| --- | --- | --- | --- |
| 83/132 (62.9%) | 129/132 (98%) | 131/132 (99.2%) | 132/132 (100%) |
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Expected blood glucose levels for people without diabetes (referenced from the American Diabetes Association Clinical Practice Recommendations 2004, Diabetes Care, Vol. 27, Supplement 1, p. S9.)
| Time | Range (mg/dL) | Range (mmol/L) |
| --- | --- | --- |
| Fasting | 70 to 100 | 3.9 to 6.1 |
| Two hours after meals | less than 140 | less than 7.8 |
N. Instrument Name:
DS-A-CHECK Blood Glucose meter
O. System Descriptions:
1. Modes of Operation:
The DS-A-CHECK blood glucose meter uses single test glucose strips. Each test strip must be replaced with a new strip for additional readings.
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Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes _______ or No ☐ X
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes _______ or No ☐ X
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
3. Specimen Identification:
There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected.
4. Specimen Sampling and Handling:
This device is intended to be used with capillary whole blood from the finger. Since the whole blood sample is applied directly to the test strip there are no special handling or storage issues.
5. Calibration:
Strip lot-specific calibration is accomplished by inserting a calibration card, which comes with each vial of DS-A-Draw-In test strips, into the DS-A-CHECK meter. The meter records the calibration coefficients and the strip lot number. When the test strip is inserted into the meter, the meter detects the lot number and matches it to the information from the calibration card.
6. Quality Control:
The sponsor has three levels of controls which are purchased separately. The mid range control is included with the kit. When a test strip is inserted into the meter, a control can be analyzed. An acceptable range for each control level is printed on the individual control vial labels. The user is referred to a troubleshooting section at the end of the control test instructions of the owner’s manual to identify possible reasons control results fall outside these ranges and is instructed to contact Customer Assistance or their health care provider.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
An ease of use study was conducted with 150 lay users who collected and analyzed their own fingerstick samples using only the labeling for guidance. See section M. 3. c for their results compared to a reference method. They were also given a survey of 12 questions to evaluate their comprehension of the written materials. On a scale of 1-5 with 5 being the easiest to use or understand, the results ranged from 4.34 for the clarity of the illustrations, to 4.89 for the overall design.
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In addition, the sponsor provided completed certificates and reports for Electrical Safety and EMC.
**Q. Proposed Labeling:**
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
**R. Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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