The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The CERA-CHEK 1070 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The CERA-CHEK 1070 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The CERA-CHEK 1070 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The CERA-CHEK 1070 Blood Glucose Test Strips are for use with the CERA-CHEK 1070 Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.

The CERA-CHEK 1070 Control Solution is for use with the CERA-CHEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The CERA-CHEK Diabetes Management Software is PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose results for effective diabetes management. It is intended for use as an accessory to compatible CERAGEM MEDISYS blood glucose monitoring systems. The CERA-CHEK Diabetes Management Software's language is English.

Device Description

The CERA-CHEK 1070 Blood Glucose Monitoring System consists of the CERA-CHEK 1070 Glucose Test Meter, CERA-CHEK 1070 Blood Glucose Test Strips with Code Key, CERA-CHEK 1070 Control Solution 1 and Control Solution 2, a Lancing device, and CERA-CHEK Diabetes Management Software and cable needed for installing the software on the PC and for transmitting data from meter. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set. CERA-CHEK Diabetes Management Software and cable are required but not included with the meter. CERA-CHEK Diabetes Management Software and cable are always provided as a set.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the analytical performance and system accuracy of the CERA-CHEK 1070 Blood Glucose Monitoring System. The acceptance criteria are implicitly defined by the reported performance relative to a reference method (YSI 2300 analyzer) and the ranges tested.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied by study design/expected standards for blood glucose meters)	Reported Device Performance
Within-run Precision	Low CV% across different glucose concentrations	Glucose concentration 30-400 mg/dL: - CV (%) range: 2.2% - 5.2%
Day-to-day Precision	Low CV% for control samples across different glucose levels	Glucose concentration 43-304 mg/dL: - CV (%) range: 2.8% - 5.5%
Linearity (r^2)	Close to 1.0, supporting claimed measurement range	Slope: 0.9782 - 0.9896 Intercept: 1.4433 - 4.4741 Corr Coeff (r^2): 0.9992 - 0.9997 (supports 20-600 mg/dL range)
Measurement Range	20-600 mg/dL	20-600 mg/dL (validated by linearity study)
System Accuracy (Technician vs YSI)	< 75 mg/dL: 100% within +/-15 mg/dL; high percentage within +/-5/10 mg/dL >= 75 mg/dL: 100% within +/-20%; high percentage within +/-5%/10%/15%	< 75 mg/dL (n=47): - 77% within +/-5 mg/dL - 89% within +/-10 mg/dL - 100% within +/-15 mg/dL >= 75 mg/dL (n=171): - 58% within +/-5% - 82% within +/-10% - 96% within +/-15% - 100% within +/-20%
System Accuracy (Lay User vs YSI)	< 75 mg/dL: 100% within +/-15 mg/dL; high percentage within +/-5/10 mg/dL >= 75 mg/dL: 100% within +/-20%; high percentage within +/-5%/10%/15%	< 75 mg/dL (n=38): - 55% within +/-5 mg/dL - 87% within +/-10 mg/dL - 100% within +/-15 mg/dL >= 75 mg/dL (n=162): - 56% within +/-5% - 76% within +/-10% - 94% within +/-15% - 100% within +/-20%
Alternate Site Testing	Similar accuracy to fingertip testing, within specified error margins for professional and lay users.	Professional (n=5 for <75, n=95 for >=75): Generally good accuracy across palm, forearm, upper arm, thigh, calf (e.g., 93-98% within +/-15% for >=75 mg/dL). Lay User (n=5 for <75, n=95 for >=75): Generally good accuracy across palm, forearm, upper arm, thigh, calf (e.g., 93-97% within +/-15% for >=75 mg/dL).
Hematocrit Range	Accurate results over the claimed range (10 - 70%)	Demonstrated accurate results for 10-70% hematocrit.
Altitude	Accurate results up to 13,200 feet	Demonstrated accurate results up to 13,200 feet.
Temperature and Humidity	Accurate results across claimed temperature (10-40°C) and humidity (10-85%) ranges	Demonstrated acceptable bias for 10-40°C and 10-85% RH.
Interference	No significant interference from listed substances at specified concentrations	Listed substances found not to interfere at specified concentrations (e.g., Acetaminophen up to 6 mg/dL, Bilirubin up to 4 mg/dL, Triglyceride up to 1,500 mg/dL). Specific limitations noted for dopamine, methyldopa, tolazamide, and xylose.
Shelf-life Stability	24 months (closed vial); 4 months (open vial)	Test strip shelf-life of 24 months (closed vial) and 4 months (open vial) supported.
Control Solution Stability	12 months (closed vial); 4 months (open vial)	Control solution shelf-life of 12 months (closed vial) and 4 months (open vial) supported.

2. Sample Sizes and Data Provenance:

Test Set Sample Sizes:
- Within-run Precision: For each of 5 glucose concentrations, 5 strip lots, and 10 meters, there were 10 measurements per strip lot per meter. This totals 5 * 5 * 10 * 10 = 2500 measurements. (The text states "a total of 100 measurements per glucose concentration", which seems to contradict the previous sentence unless it's per meter type across strip lots, or a summary. Taking the more detailed description, it's 2500 total).
- Day-to-day Precision: For each of 3 control levels, 1 strip lot (per glucose level, so effectively 3 lots used in total), and 10 meters, measured once per day over 20 days. This totals 3 * 1 * 10 * 20 = 600 measurements per each of the three levels, for a grand total of 1,800 measurements.
- Linearity/Assay Reportable Range: 9 (or 10) glucose samples, each analyzed 5 times using 3 lots of test strips. This would be 9 (or 10) * 5 * 3 = 135 to 150 measurements.
- System Accuracy Study (Technician vs YSI):
  - Fingertip samples: 200 participants (collected and tested twice by themselves, and once by healthcare professional).
  - Contrived samples: 20 samples.
  - Total sample comparisons to YSI for technician: 171 (≥75 mg/dL) + 47 (<75 mg/dL) = 218 data points.
  - Total sample comparisons to YSI for user: 162 (≥75 mg/dL) + 38 (<75 mg/dL) = 200 data points.
- Alternate Site Test: A total of 100 volunteer samples. For each alternate site (Palm, Forearm, Upper Arm, Thigh, Calf), there were 5 samples < 75 mg/dL and 95 samples >= 75 mg/dL, for both professional and lay users.
- Hematocrit Study: Five measurements for each combination of glucose concentration and hematocrit level (specific total N not given, but glucose range 21-529 mg/dL and hematocrit range 10-70%).
- Altitude Study: Three lots of test strips and three meters were used (specific total N not given, but 3 glucose concentrations).
- Temperature and Humidity Studies: Three test strip lots, three glucose concentrations, twelve combinations of temp/humidity, replicates of three for each combination/glucose/meter (specific total N not given).
- Interference Studies: Whole blood from healthy volunteers (exact number of volunteers not specified, but multiple glucose levels and interferent concentrations tested).
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. However, given the manufacturer is based in Korea (Republic of Korea), it is highly probable the studies were conducted there. The studies appear to be prospectively designed clinical and analytical performance studies conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth: No specific number of experts are explicitly stated as establishing the ground truth for the test set in the way one might for diagnostic imaging studies.

For the analytical and system accuracy studies, the "ground truth" was established by laboratory reference methods, specifically the YSI 2300 Glucose analyzer for glucose measurements. The YSI 2300 is calibrated using a NIST traceable glucose standard, implying a highly accurate and standardized method for ground truth determination.
For the usability study, "untrained lay users" were involved, but their assessment was on the "readability of the labeling" and "ease of use," not on establishing diagnostic ground truth.

4. Adjudication Method for the Test Set: Not applicable. The ground truth for the glucose measurements was established by a single, highly accurate laboratory reference method (YSI 2300), not through a consensus or adjudication process among multiple human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The studies assessed the standalone performance of the device (both technician and lay user operated) against a reference method. There is no comparison of "human readers improve with AI vs without AI assistance" as this is a blood glucose meter, not an AI-assisted diagnostic imaging device for human interpretation.

6. Standalone (Algorithm Only) Performance: Yes, standalone performance was done for the device in the context of a blood glucose meter. The "Technician vs YSI" data directly represents the standalone performance of the device when operated by a trained professional against the gold standard (YSI). The "Lay User vs YSI" data represents the performance when operated by the intended end-user.

7. Type of Ground Truth Used:
The primary ground truth used throughout the performance studies (precision, linearity, system accuracy, alternate site testing, hematocrit, altitude, temperature/humidity, interference) was laboratory reference method measurements obtained from the YSI 2300 Glucose analyzer, which is calibrated using a NIST traceable glucose standard. This is a highly objective and quantitative ground truth.

8. Sample Size for the Training Set: The document does not specify a separate "training set" sample size. For medical devices like blood glucose meters, the development and calibration ("training") of the device's algorithms or underlying chemical reactions often occur prior to these validation studies. These studies primarily serve as external validation or "test sets" to demonstrate the final product's performance. The information provided heavily details these validation studies.

9. How Ground Truth for the Training Set Was Established: As above, specific details on a "training set" and its ground truth establishment are not provided in this 510(k) summary. The development process would typically involve extensive internal testing and calibration against reference methods (like the YSI 2300) to fine-tune the device's performance before formal validation studies are conducted. The traceability to the YSI 2300 analyzer and NIST traceable glucose standard suggests that this highly accurate reference method would have been central to any internal calibration or "training" process.

Summary

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K 131727

FEB 2 8 2014

CERAGEM Medisys Inc. www.ceragemmedisys.com

510(k) Summary

In accordance with the requirements of 21 CFR.807.92, the following information about 510(k) safety and effectiveness is being submitted.

1. Submitter
  CERAGEM Medisys Inc.

16 Jeongji1-gil. Seonggeo-eup. Seobuk-gu, Cheonan-si. Chungcheongnam-do. 331-833. Korea Phone : (+82) 41-529-8422 Fax : (+82) 41-551-0767

1. Date Prepared
  February 28, 2014
1. Device Name
  Common name : CERA-CHEK 1070 Blood Glucose Monitoring System

Classification : Class II

(Regulation: 21 CFR § 862.1345)

Product Code : LFR, NBW(Blood Glucose Test System, Over the Counter), JJX, JQP

Predicate Device 4.

CERA-CHEK 1070 Blood Glucose Monitoring System is substantially equivalent to Ascensia® CONTOUR ® Blood Glucose Monitoring System described as below.

(1) Device Name: Ascensia® CONTOUR ® Blood Glucose Monitoring System
(2) Manufacturer: Bayer HealthCarc, LLC.
(3) 510(K) Number: K062058

ર. Device Description

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provided as a set. CERA-CHEK Diabetes Management Software and cable are required but not included with the meter. CERA-CHEK Diabetes Management Software and cable are always provided as a set.

6. Intended Use

CERAGEM

MEDISYS

The CERA-CHEK 1070 Control Solution is for use with the CERA-CHIEK 1070 Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

1. Comparison to Predicate Device

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Image /page/2/Picture/0 description: The image shows the logo for CERAGEM MEDISYS. The word "CERAGEM" is in large, bold, sans-serif font on the top line. Below that, in a smaller font, is the word "MEDISYS". To the right of the words is a stylized geometric shape.

CERAGEM Medisys Inc. www.ceragemmedisys.com

	Comparison
Item	Device	Predicate
Device Name	CERA-CHEK 1070	Ascensia® CONTOUR®
	Similarities
Detection Method	Amperometry	Amperometry
Enzyme	Glucose dehydrogenase(FAD-GDH)	Glucose dehydrogenase(FAD-GDH)
Test Time	5 seconds	5 seconds
	Differences
Coding	No coding	No coding
Memory	1000 blood glucose test resultswith date and time	480 blood glucose test resultswith date and time
Test range	20-600 mg/dL	10-600 mg/dL
Sample Volume	0.5 uL	0.6 uL
Humidity range	10-85%	10-93%
Temperature range	50-104°F10-40°C	41~113°F5-45°C
Power(Battery)	One 3-volt lithium battery(CR2032)	Two 3-volt lithium batteries(DL2032 or CR2032)
Level of QC	2 Levels (Control 1, Control 2)	3 Levels (Low, Normal, High)
Dimensions	94mm(H) x 53.6(W) x 14.9mm(T)	77mm(H) x 57mm(W) x 19mm(T)
Weight	40g	47.5g
Hematocrit range	10-70%	20-60%

Conclusion

As the comparison table, the CERA-CHEK 1070 Blood Glucose Monitoring System have same detection method, test range, and test time. Furthermore, the CERA-CHEK 1070 Blood Glucose Monitoring System is also using same enzyme and mediator. To sum up with the similarities, the CERA-CHEK 1070 Blood Glucose Monitoring System is similar with the predicate device because most of the specifications deciding the characteristic of the device are same. In conclusion, despite of the difference such as memory, coding, and etc, the CERA-CHEK 1070 Blood Glucose Monitoring System is substantially equivalent as compared to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for CERAGEM MEDISYS. The text "CERAGEM" is in bold, uppercase letters on the top line. Below that, the text "MEDISYS" is in smaller, uppercase letters. To the right of the text is a stylized graphic of a cube with a smaller cube inside.

◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆ ◆

1. Performance Characteristics

1. Analytical performance

A. Precision/Reproducibility

(1) Within-run Precision

Within-run precision was evaluated by analyzing venous whole blood samples spiked to five different glucose concentrations. The hematocrit of all samples was between 35 and 50%. Five different lot numbers of test strips and ten meters were used in the study and each of the samples was measured ten times per strip lot number per meter for a total of 100 measurements per glucose concentration. The samples were analyzed by one operator in one day.

Interval	1	2	3	4	5
Glucose concentration	30~50	51~110	111~150	151~250	251~400
YSI (mg/dL)	44	96	127	226	323
Mean	45.2	97.6	129.1	228.3	326.1
STD(mg/dL)	2.4	3.1	4.1	6.9	7.3
CV (%)	5.2	3.1	3.2	3.0	2.2

(2) Day to day precision

Day to day precision was evaluated by analyzing control samples at three different concentrations. Three lot numbers of test strips (one per glucose level) and ten meters were used in the study. Each of the controllevels was measured once per day over twenty. Each of the control levels was measured once per strip lot number per meter. In total, 600 measurements were taken for each of the three levels. Results are summarized below:

Interval	1	2	3
Glucose concentration	30~50	96~144	280~420
YSI, mg/dL	43	108	304
Mean	42.6	108.4	303.8
STD(mg/dL)	2.3	3.4	8.6
CV(%)	5.5	3.2	2.8

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B. Linearity/assay reportable range

CERACE

MEDISYS

The sponsor evaluated the linearity of the meter by preparing a series of 9 glucose samples, following the dilution scheme in CLSI EP6-A, and producing target values of 11, 52, 89, 157, 234, 310, 386, 461, 531, and 607 mg/dL.

·Each of the ten levels was analyzed five times using three lots of test strips. All samples were also tested on the YSI 2300 analyzer. Linear regression of the data produced the following:

Strip Lot	Slope	Intercept	Corr Coeff ( $r^2$ )
1	0.9896	1.4433	0.9995
2	0.9786	2.4223	0.9997
3	0.9782	4.4741	0.9992

The results of the study support the sponsor's claimed glucose measurement range of 20 - 600 mg/dL.

C. Traceability, Stability, Expected values (controls, calibrators, or methods)

The CERA-CHEK 1070 Blood Glucose Monitoring System is traccable to the YSI 2300 Glucose analyzer which is calibrated using the YSI 2747 Glucose Standard which is a NIST traceable glucose standard.••

Test strip shelf-life stability (closed vial) was assessed in an accelerated study with real time studies ongoing, The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the claimed shelf life of 24 months when stored at 1- 32° C and 10-85% RH.

Test strip in-use stability (open vial) was assessed in real time studies. The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the open vial stability of four months when stored at 1- 32° C and 10-85% RH.

Control shelf-life stability (closed vial) was assessed an accelerated study with real time studies ongoing. The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the claimed shelf life of 12 months when stored at 1- 32° C and below 50% RH.

Control in-use stability (open vial) was assessed in real-time studies. The protocols and acceptance criteria were reviewed and found to be acceptable. The testing supported the open vial stability of four months when

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stored at 1- 32° C and below 50% RH.••

D. Detection Limit

CERAGEM

MEDISYS

The measuring range of the device is 20 - 600 mg/dL. This range was validated by the linearity study.

E. Analytical specificity

The sponsor performed interference studies in accordance with CLSI EP7-A. Testing was performed in parallel (control samples vs. test samples) to minimize the effects of glucose metabolism. Whole blood was drawn into K3-EDTA anticoagulant tubes from healthy volunteers who were not on any medications. The glucose levels tested were 64, 151, and 257 mg/dL. The highest level was achieved by spiking. A low and high concentration of each potential interferent was then tested at each glucose level. The following substances were found not to interfere at the concentrations listed:

Substance	No interference up to:
Acetaminophen	6 mg/dL
Ascorbic acid	4 mg/dL
Dopamine	5 mg/dL
Ibuprofen	40 mg/dL
Metformin	4 mg/dL
Methyldopa	5 mg/dL
Salicylic acid	50 mg/dL
Uric acid	10 mg/dL
Bilirubin	4 mg/dL
Triglyceride	1,500 mg/dL
Cholesterol	500 mg/dL
Creatinine	10 mg/dL
Galactose	100 mg/dL
Gentisic acid	2 mg/dL
Glutathione	3 mg/dL
Hemoglobin	20 g/dL
L-dopa	4 mg/dL

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Maltose	100 mg/dL
Sodium	150 mmol/L
Tolbutamide	64 mg/dL
Tolazamide	5 mg/dL
Xylose	10 mg/dL
Mannitol	800 mg/dL
Sorbitol	100 mg/dL
Xylitol	100 mg/dL
Lactitol	100 mg/dL
Isomalt	100 mg/dL
Maltitol	100 mg/dL
Hydrogenated starchhydrolysates	100 mg/dL

The sponsor has the following limitations in their labeling

� High concentrations of dopamine, methyldopa, and Tolazamidc may cause inaccurate test results
. Do not use during or soon after xylose absorption testing. Xylose (>10mg/dL) in the blood will cause interference.

2. Comparison studies

A. Method comparison with predicate device

For the user performance study, 200 participants collected and tested twice their own fingerstick sample in single measurements on the CERA-CHEK 1070 BGMS. The healthcare professional tested the collected samples of 200 participants and 20 contrived samples on CERA-CHEK 1070 BGMS. Within five minutes, fingerstick sample was collected from each participant by a healthcare professional for the system accuracy study and was tested on the YSI 2300 reference analyzer.

System Accuracy Study

Difference distribution for glucose concentration < 75mg/dL

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	Technician	User
	Result	Result
within +/-5mg/dL	77%(36/47)	55%(21/38)
within +/-10mg/dL	89%(42/47)	87%(33/38)
within +/-15mg/dL	100%(47/47)	100%(38/38)

Note: One contrived sample was <20 mg/dL and therefore not included in data analysis.

Difference(%) distribution for glucose concentration ≥ 75mg/dL

	Technician	User
	Result	Result
within ±5%	58%(100/171)	56%(91/162)
within ±10%	82%(140/171)	76%(123/162)
within ±15%	96%(164/171)	94%(152/162)
within ±20%	100%(171/171)	100%(162/162)

Note: One contrived sample was >600 mg/dL and therefore not included in data analysis.

Linear regression

CERAGEM

••

MEDISYS

	Slope	Intercept	Correlation coefficient
	(95% Confidence Interval)
Technician vs YSI	1.0365	-5.5769	0.9948
	(1.0223~1.0507)	(-8.2708~-2.8831)
User vs YSI	1.0322	-3.0441	0.9901
	(1.0117~1.0527)	(-6.4963~0.1081)

B. Alternate Site Test

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Image /page/8/Picture/1 description: The image contains text describing a study performed with a total of 100 volunteer samples. Samples from an alternative site were measured by volunteers and professionals using a meter. The samples were also measured using a reference analyzer.

Difference distribution for glucose concentration <75mg/dL

- Professional

CERAGEMO

MEDISYS

	Palm capillary blood	Forearm capillary blood	Upper arm capillary blood	Thigh capillary blood	Calf capillary blood
within±5mg/dL	80%(4/5)	60%(3/5)	100%(5/5)	80%(4/5)	80%(4/5)
within±10mg/dL	100%(5/5)	100%(5/5)	100%(5/5)	80%(4/5)	100%(5/5)
within±15mg/dL	100%(5/5)	100%(5/5)	100%(5/5)	100%(5/5)	100%(5/5)

- lay user

	Palm capillaryblood	Forearm capillaryblood	Upper arm capillaryblood	Thigh capillaryblood	Calf capillaryblood
within±5mg/dL.	80%(4/5)	80%(4/5)	80%(4/5)	80%(4/5)	80%(4/5)
within±10mg/dL	100%(5/5)	100%(5/5)	100%(5/5)	100%(5/5)	100%(5/5)
within±15mg/dL	100%(5/5)	100%(5/5)	100%(5/5)	100%(5/5)	100%(5/5)

Difference distribution for glucose concentration ≥75mg/dL

- Professional

	Palm capillaryblood	Forearm capillaryblood	Upper arm capillaryblood	Thigh capillaryblood	Calf capillaryblood
within±5%	73%(70/95)	59%(56/95)	65%(62/95)	66%(63/95)	64%(61/95)
within±10%	78%(74/95)	71%(67/95)	77%(73/95)	77%(73/95)	71%(67/95)
within±15%	93%(88/95)	95%(90/95)	95%(90/95)	97%(92/95)	98%(93/95)
within±20%	100%(95/95)	100%(95/95)	100%(95/95)	100%(95/95)	100%(95/95)

- Lay user

	Palm capillary	Forearm capillary	Upper arm capillary	Thigh capillary	Calf capillary
	blood	blood	blood	blood	blood
within±5%	62%(59/95)	62%(59/95)	64%(61/95)	65%(62/95)	57%(54/95)
within±10%	66%(63/95)	73%(69/95)	72%(68/95)	72%(68/95)	75%(71/95)
within±15%	94%(89/95)	93%(88/95)	96%(91/95)	94%(89/95)	97%(92/95)

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CERAGEM
MEDISYS
CERAGEM Medisys Inc.
www.ceragemmedisys.com
within±20%	100%(95/95)
	100%(95/95)
	100%(95/95)
	100%(95/95)
	100%(95/95)

Linear regression and correlation coefficient.

Professional

**	Slope	Intercept	Correlation coefficient
	(95% confidence interval)
Palm capillary vs YSI	1.0230(1.0054~1.0406)	2.1615(-1.4008~5.7239)	0.9963
Forearm capillary vs YSI	1.0519(1.0347~1.0692)	-0.0445(-3.5308~3.4419)	0.9967
Upper arm capillary vs YSI	1.0396(1.0202~1.0590)	0.0729(-3.8584~4.0043)	0.9957
Thigh capillary vs YSI	1.0303(1.0109~1.0496)	0.5266(-3.3818~4.4350)	0.9957
Calf capillary vs YSI	1.0364(1.0144~1.0583)	0.7075(-3.7344~5.1494)	0.9945

Lay user

	Slope	Intercept	Correlation coefficient
	(95% confidence interval)
Palm capillary vs YSI	1.0504	-1.5331	0.9955
	(1.0305~1.0704)	(-5.5767~-2.5105)
Forearm capillary vs YSI	1.0317	2.1956	0.9965
	(1.0143~1.0491)	(-1.3207~-5.7120)
Upper arm capillary vs YSI	1.0254	1.9080	0.9956
	(1.0059~1.0448)	(-2.0296~-5.8455)
Thigh capillary vs YSI	1.0405	-0.9615	0.9933
	(1.0163~1.0648)	(-5.8634~-3.9404)
Calf capillary vs YSI	1.0352	1.7561	0.9962
	(1.0170~1.0535)	(-1.9340~-5.4461)

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3. Other Supportive Instrument Performance Characteristics Data Not Covered In the " Performance Characteristics" Section above

A. Hematocrit study

MEDISYS

The effect of different hematocrit levels was evaluated using venous whole blood samples with hematocrit levels across the claimed range and altered to glucose concentrations from 21 - 529 mg/dL. There were five measurements for each combination of glucose concentration and hematocrit level. The results demonstrated that CERA-CHEK 1070 Blood Glucose Monitoring System produces accurate results over the claimed hematocrit range of 10 - 70%.

B. Altitude study

A study was conducted to evaluate the effect of altitude on the device. In this evaluation, venous blood at glucose concentrations of approximately 100. 200, and 300 mg/dL was tested using a decompression chamber to simulate the effects of altitude. Three lots of test strips and three meters were used. Each blood sample was also tested by the YSI 2300 analyzer. The meter readings obtained were compared to the YSI method and the percent bias was determined at each level against the YSI results demonstrated that the CERA-CHEK 1070 Blood Glucose Monitoring System produces accurate results at altitudes up to 13,200 feet.

C. Temperature and humidity studies

In this study, three test strip lots were tested on three glucose concentrations (approximately 45, 120, and 300 mg/dL) at twelve combinations of temperature and humidity. Each combination of environmental conditions / glucose concentration / meter was tested in replicates of three. The temperatures tested ranged from a low of 10.0° C to a high of 41.2° C. The relative humidity tested ranged from 10.3% -86.6%. Glucose concentrations were verified by the YSI reference method. The bias relative to the reference method was acceptable to support the claim that temperatures from 10 – 40° C (50 – 104° F) and relative humidity from 10 - 85% do not significantly affect the glucose results.

D. Infection Control Studies

The CERAGEM MEDISYS CERA-CHEK 1070 Blood Glucose Monitoring System is intended for singlepatient use only. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing facility demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, CaviWipes (EPA Registration Number 46781-8). Robustness

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Image /page/11/Picture/1 description: The image shows the logo for CERAGEM MEDISYS. The word "CERAGEM" is in large, bold, black letters on the top line. Below that, the word "MEDISYS" is in smaller, bold, black letters. To the right of the word "CERAGEM" is a black hexagon with a white plus sign in the center.

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studies were also performed by the sponsor demonstrating that there was no change in performance or external materials for the meter and lancing device after 1825 cleanings and 1825 disinfection steps with CaviWipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

E. Usability Study

A usability study was performed to assess the readability of the labeling by recruiting untrained lay users who were provided with the test kit and labeling. These lay users also completed a questionnaire regarding the clarity of the instructions and the ease of use of the majority of the users responded that they understood the instructions and were able to successfully operate the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/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 stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 28, 2014

CERAGEM MEDISYS, INC. HAKSUNG KIM 3-2, JEONGCHON-RI, SEONGGEO-EUP, SEOBUK-GU, CHEONAN-SI, CHUNGCHEONGNAM-DO 331-833 REPUBLIC OF KOREA

Re: K131727

Trade/Device Name: CERA-CHEK 1070 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: LFR, NBW, JJX, JOP Dated: January 06, 2014 Received: January 10, 2014

Dear Haksung Kim:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Haksung Kim

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, plaase note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF). Past 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K131727

Device Name: CERA-CHEK 1070 Blood Glucose Monitoring System

Indications for Use:

Prescription Use And/Or (21 CFR Part 801 Subpart D)

Over the Counter Use V (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 Diagnostics and Radiological Health (OIR)

Katherine Serrano -5

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_k131727

Page I of I

Regulation Number and Section

§ 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.