The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase (AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.

The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

Device Description

The skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (private label) and Comprehensive Metabolic Panel is an automatic chemistry system intended for use in clinical laboratories or point-of-care locations. The system consists of a portable analyzer and single-use disposable reagent panel discs.

The analyzer utilizes precision photometric measurement technology, combined with the use of specific reagent panel disc, to measure the amount of substance in blood. The analyzer measures absorbance change of each reaction well in reagent panel disc and covert it to a concentration value for each analyte included on the panel.

The skyla and Minicare Comprehensive Metabolic Panel reagent disc (which contains the Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Blood Urea Nitrogen and Creatinine test systems) is designed to separate a heparinized venous whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

AI/ML Overview

The Lite-On Technology Corp.'s Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, and Minicare C300 Clinical Chemistry Analyzer (K171971) were evaluated for substantial equivalence. The acceptance criteria and performance data are primarily based on precision, matrix comparison, detection limits, linearity, and interference testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's performance and the established clinical laboratory standards (e.g., CLSI guidelines, recovery within 90-110% for interference). The reported device performance aligns with these expectations.

Performance Characteristic	Acceptance Criteria (Implied / Stated)	Device Performance (Reported)
Internal Precision / Reproducibility (CV%)	Less than 10%	ALP: 1.7 - 4.3% ALT: 3.0 - 6.8% AST: 2.2 - 9.7% BUN: 3.0 - 3.8% CREA: 2.4 - 8.5% (All results within 10% CV)
Matrix Comparison (Correlation Coefficient)	High correlation (e.g., >0.99) with predicate/reference method for Serum vs. Plasma, Plasma vs. WB, WB vs. Serum	ALP: 0.9997 - 0.9998 ALT: 0.9997 - 0.9998 AST: 0.9987 - 0.9990 BUN: 0.9988 - 0.9990 CREA: 0.9964 - 0.9971 (All show strong correlation)
Detection Limit (LoD/LoQ)	LoD/LoQ should meet requirements for total error for each analyte.	ALP: LoD/LoQ: 4.405 U/L ALT: LoD/LoQ: 5.228 U/L AST: LoD/LoQ: 11.690 (LoQ) / 12.089 (LoD) U/L BUN: LoD/LoQ: 1.526 mg/dL CREA: LoD/LoQ: 0.262 mg/dL (All LoD/LoQ met requirements for total error)
Linearity (R2 )	High linearity (e.g., >0.99) across the claimed measuring range.	ALP: 0.9967 (range 30-2083 U/L vs. claimed 41-1500 U/L) ALT: 0.9999 (range 17-535 U/L vs. claimed 20-500 U/L) AST: 0.9984 (range 16-1021.3 U/L vs. claimed 20-1000 U/L) BUN: 0.9979 (range 1.8-126.9 mg/dL vs. claimed 2-120 mg/dL) CREA: 0.9993 (range 0.48-21.48 mg/dL vs. claimed 0.6-20 mg/dL) (All show strong linearity within and beyond claimed ranges)
Endogenous Interference	Recoveries between 90% and 110% of the neat value.	No significant effect (>10% effect) from Hemolysis (60-66 mg/dL), Icterus (13-32 mg/dL), Lipemia (189-1032 mg/dL) for any tested analyte.
Exogenous Interference	No significant interference (>10% shift)	Most substances showed no significant interference. Ibuprofen showed 11.8% Inc. for CREA, Salicylic acid showed 16.3% Dec. for ALT, and Theophylline showed 14.4% Dec. for ALP.
POC Method Comparison (Correlation Coefficient)	High correlation (e.g., >0.99) with a comparative clinical analyzer.	ALP: 0.9987 (WB), 0.9986 (Serum) ALT: 0.9980 (WB), 0.9983 (Serum) AST: 0.9988 (WB), 0.9986 (Serum) BUN: 0.9981 (WB), 0.9977 (Serum) CREA: 0.9975 (WB), 0.9975 (Serum) (All show strong correlation)
POC Precision (CV%)	Less than 10% between operators.	All analytes across three concentration levels at three POC sites showed CVs less than 10%.
Electrical Safety and EMC	Compliance with IEC 60601-1-2.	Passed tests according to IEC 60601-1-2.

2. Sample Sizes Used for the Test Set and Data Provenance

Internal Precision/Reproducibility: 80 runs per level (quadruplicate testing a day for 20 working days) for each of the three serum levels for all 5 analytes. Data provenance is not specified (e.g., country of origin) but refers to "patient serum samples." Implied prospective collection for the study.
Matrix Comparison: 40 human samples. Data provenance not specified. Implied prospective collection for the study.
Detection Limit: LoB: 60 measurements of a near-zero sample over 10 days. LoD/LoQ: serum samples containing very low concentrations, tested in triplicate using 2 lots of reagent discs for 10 days. Data provenance not specified. Implied prospective collection.
Linearity: 9 intermediate dilutions created from high and low human serum pool samples, plus spiked samples. Data provenance not specified. Implied prospective collection.
Endogenous Interferences: Not explicitly stated, but implies multiple samples to test two different concentrations (normal and abnormal) of analytes against specified interference levels. Data provenance not specified. Implied prospective collection.
Exogenous Substances: Two concentrations (low and high level) of samples for each of the 10 potential interferents. Data provenance not specified. Implied prospective collection.
Point-of-Care (POC) Method Comparison: Over 120 heparinized venous whole blood and serum samples for each analyte. Data provenance not specified; likely collected from the three POC sites, implying prospective collection.
Point-of-Care (POC) Precision Studies: Three levels of human serum samples from POC sites, assayed in quadruplicate twice a day for 20 days. Data provenance not specified. Implied prospective collection.
Point-of-Care (POC) Whole Blood Precision: Not explicitly stated, but tabular data suggests multiple analyses (mean, SD, CV) for low, medium, and high samples across 3 POC sites and multiple operators (OP1, OP2, OP3).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This type of submission (510k for a clinical chemistry analyzer) does not typically involve human experts establishing a "ground truth" for the test set in the same way an image analysis or diagnostic AI device would. Instead, the ground truth is established by:

Reference Methods/Materials: Traceability to established reference methods (e.g., IFCC reference method for ALT/ALP/AST, CDC reference method for BUN, IDMS Reference Method for CREA) and reference materials (NIST SRM967).
Comparative Clinical Analyzers: For method comparison studies, the Beckman Coulter AU2700 clinical analyzer served as the comparative (reference) method.

Therefore, the "experts" in this context are the established, validated, and traceable laboratory methods and instruments, rather than individual human practitioners.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic test performance for clinical chemistry analyzers is typically evaluated by statistical comparison to a reference method or established clinical ranges, not by an adjudication process as seen in clinical trial settings for diagnostic imaging.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where multiple human readers interpret cases with and without AI assistance. This submission is for a clinical chemistry analyzer.

However, the "POC Precision studies" did evaluate performance across multiple operators (9 operators) at three POC sites. This demonstrates inter-operator variability, which is a related concept to multi-reader studies in a laboratory context, but it does not measure an "improvement with AI vs. without AI assistance" since the device itself is the primary measurement tool, not an AI assistant to a human reader.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the studies presented are generally "standalone" performance evaluations of the device (skyla/Minicare Clinical Chemistry Analyzer with Comprehensive Metabolic Panel) itself. The device automatically measures analytes and displays results; there isn't an "algorithm only" component separate from the integrated device performance. All performance data (precision, linearity, detection limits, interference) are solely based on the device's output.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through:

Traceability to Reference Methods/Materials: For calibration and analytical accuracy (e.g., IFCC, CDC, IDMS reference methods, NIST reference materials).
Comparative Clinical Analyzers: The Beckman Coulter AU2700 served as the comparative method for method comparison studies, essentially acting as the "ground truth" or reference for evaluating the test device's performance on patient samples.
Known Concentrations: For studies like linearity, detection limits, and interference, samples with known or spiked concentrations are used.

8. The Sample Size for the Training Set

This document does not specify a separate "training set" in the context of machine learning or AI. This device is a traditional in-vitro diagnostic (IVD) clinical chemistry analyzer. Its development would involve internal validation and optimization processes by the manufacturer, which might loosely be considered "training," but it's not described as an AI model training set with a specific size or provenance.

9. How the Ground Truth for the Training Set was Established

As this is a traditional IVD device, the concept of a "training set" for an AI model's ground truth is not applicable in the way it would be for AI-powered diagnostic software. The "ground truth" for the development and internal validation of such a device is established through:

Chemical Principles and Reactions: The underlying scientific principles of colorimetry and specific reagent reactions form the fundamental 'ground truth' for measurement.
Calibration Standards: The device is calibrated using standards whose concentrations are traceable to recognized reference methods and materials, ensuring accurate quantitative measurements.
Quality Control Materials: Known quality control materials are used to ensure the device performs within expected ranges over time.

These elements collectively serve as the basis for ensuring the device's accuracy and reliability during its design, development, and manufacturing phases.

Summary

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January 25, 2018

Lite-On Technology Corp. H.S.P.B. % Feng-Yu Lee Principal Consultant Dynamic Biotech, Inc. dba IVDD Regulatory Consultant 29222 Rancho Viejo Rd., Suite 218 San Juan Capistrano, CA 92675

Re: K171971

Trade/Device Name: Comprehensive Metabolic Panel skyla Clinical Chemistry Analyzer Minicare C300 Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE, CKA, CDN, CGX, CIT, JJG Dated: December 4, 2017 Received: December 13, 2017

Dear Feng-Yu Lee:

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 Part

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801 and Part 809); medical device 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Kellie B. Kelm -S

for 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) K171971

Device Name

Comprehensive Metabolic Panel, skyla Chemistry Analyzer,Minicare C300 Clinical Chemistry Analyzer

Indications for Use (Describe)

Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal dialysis, and as a calculation basis for measuring other urine analytes.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K171971.

APPLICANT INFORMATION: I.

Name:	Lite-On Technology Corp.Hsinchu Science Park Branch
Address:	8, Dusing Road, Hsinchu Science Park, Hsinchu30078, Taiwan, R.O.C.
Phone:	+886-3-5787722
Fax:	+886-3-5795393
	c/o IVDD Regulatory Consultant

29222 Rancho Viejo Road, Suite 218, San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 1-949-218-0928 Fax Number:

Date Summary Prepared: January 24th, 2018

II. DEVICES INFORMATION:

Trade Name:

skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer Comprehensive Metabolic Panel

Classification name, product code, and regulation number

Classification Name	ProductCode	Regulation number/Class
Analyzer, chemistry, centrifugal, for clinical use	JJG	862.2140/ Class I, 510(k)exempt*
Alanine amino transferase (ALT/SGPT) testsystem	CKA	862.1030/ Class I
Alkaline phosphatase or isoenzymes test system	CJE	862.1050/ Class II
Aspartate amino transferase (AST/SGOT) testsystem	CIT	862.1100/ Class II,510(k) exempt*

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Image /page/4/Picture/0 description: The image shows the logo for LITEON. The logo consists of the word "LITEON" in a bold, sans-serif font. Below the logo is the text "LITE-ON Tech. Corp.", which is the company's name. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

Urea nitrogen test system	CDN	862.1770 / Class II
Creatinine test system	CGX	862.1225/Class II

Meets limitations of exemption per 21 CRF § 862.9 (c)(9)

III. PREDICATE DEVICE

The following table identifies the legally marketed device to which Lite-On claims equivalence.

Subject Device	Predicate Device
	Predicate Device	Manufacturer	510(k) Number
skyla Clinical ChemistryAnalyzer	PiccoloTM	Abaxis, Inc.	K942782
ComprehensiveMetabolic Panel	ComprehensiveMetabolic Panel	Abaxis, Inc.	K942782 K950164

IV. DEVICE DESCRIPTION:

V. INDICATIONS FOR USE

The Comprehensive Metabolic Panel is intended to be used for the quantitative determination of Alkaline Phosphate (ALP), Alanine Aminotransferase (ALP/GPT), Aspartate Aminotransferase

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(AST/GOT), Blood Urea Nitrogen (BUN) and Creatinine (CREA) in concentrations in lithium-heparinized venous whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

-Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
-Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
-Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Blood urea nitrogen measurements are used in the diagnosis and treatment of certain types of renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

skyla Clinical Chemistry Analyzer

Minicare C300 Clinical Analyzer

The Minicare C300 Clinical Analyzer is an in-vitro diagnostic device for the quantitative determination of clinical chemistry analytes in lithium-heparinized venous whole blood, heparinized plasma, or serum. It is for clinical laboratory and point-of-care use.

VI. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE

The tables below outline the technological characteristics of the skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer and Comprehensive Metabolic Panel Reagent in comparison to the legally marketed predicate devices.

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Item	Clinical Chemistry Analyzerskyla / Minicare C300	Predicate DeviceK942782
Intended use	quantitativedeterminationofclinical chemistry analytesinlithium-heparinized venous wholeblood, heparinized plasma,orserum. It is for clinical laboratoryand point-of-care use.	Point-of-Care,quantitativeofdeterminationclinicalchemistryanalytesinheparinizedwholeblood,heparinized plasma, or serum.
Light source	LEDs	Xenon arc stroboscopic lamp
Detector	Photodiode	Same
Height x Widthx Depth	Skyla: 300 x 223 x 285 mmMinicare: 200 x 185 x 262 mm	242 x 153 x 292mm
Test time	15 min.	12 min.
Methodofmeasurements	Colorimetry (Absorbance)	Same
Liquid handling	Centrifugation technology	Same
Bloodseparationfunction	Integrated in the device	Same
Testingenvironment	Clinical laboratory, point-of-care	Same
Assaytemperature	37°C (98.6°F)	Same
Powerrequirement	100-240 volts AC; 50-60 Hz; or 12volts DC, 5.0A	100-240 volts AC; 50-60 Hz;or 15 volts DC, 5.0A
Electromagneticcompatibilityelectricalandsafety	IEC 60601-1-2	Same
OperatingTemperature	50 - 90°F (10 - 32°C)	59 - 90°F (15 - 32°C)
Sample Volume	200 µL	100 µL
Item	Subject Device	Predicate Device K942782/K950164
Classification product code	ALT: CKAALP: CJEAST: CITBNU: CDNCREA: CGX	Same
Intended use	Quantitative determination of alanine aminotransferase	Same
Testing Environment	Clinical lab or point-of-care setting	Same
Specimen Type	Human lithium heparinized venous whole blood, lithium heparinized plasma, and serum	Same
Detection Wavelength	ALT: 340 nmALP: 405 nmAST: 340 nmBUN: 340 nmCREA: 546 nm	ALT: 340 - 405 nmALP: 405 - 500 nmAST: 340 - 405 nmBUN: 340 - 405 nmCREA: 550 nm - 600 nm
Detection Limit	ALT: 2.350 U/LALP: 4.405 U/LAST: 6.695 U/LBUN: 1.526 mg/dLCREA: 0.262 mg/dL	ALT: 5 U/LALP: 5 U/LAST: 5 U/LBUN: 2.0 mg/dLCREA: 0.2 mg/dL
Reportable Range	ALT: 20 - 500 U/LALP: 41 - 1500 U/LAST: 20 - 1000 U/LBUN: 2 – 120 mg/dLCREA: 0.6 – 20 mg/dL	ALT: 5 - 2000 U/LALP: 5 - 2400 U/LAST: 5 - 2000 U/LBUN: 2 – 180 mg/dLCREA: 0.2 - 20 mg/dL

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Comprehensive Metabolic Panel, Alanine aminotransferase

VII. PERFORMANCE DATA

Brief Discussion of Non-Clinical Tests Performed for Determination of Substantial 1. Equivalence are as follows:

a. Internal precision/ Reproducibility
Internal precision was conducted using CLSI EP5 guidelines. Three levels (low, Middle, high) of patient serum samples were tested quadruplicate a day for 20 working days (80 runs). Each of 2 runs per day was separated by at least 4 hours.

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The results were summarized as below table. All six test systems showed a good precision with %CV being less than 10% for three different levels of patient serum samples.

Test System	Level	Mean	Within-Run		Total
			SD	%CV	SD	%CV
ALP (U/L)n = 80 per level	Level 1	71.9	1.8	2.5	1.8	2.5
	Level 2	788.8	33.9	4.3	33.9	4.3
	Level 3	1403.1	23.4	1.7	24.2	1.7
ALT (U/L)n = 80 per level	Level 1	39.9	2.7	6.7	2.7	6.8
	Level 2	194.6	6.1	3.1	6.3	3.2
	Level 3	478.0	14.5	3.0	14.8	3.1
AST (U/L)n = 80 per level	Level 1	36.9	3.0	8.1	3.6	9.7
	Level 2	282.4	6.2	2.2	6.3	2.2
	Level 3	839.7	18.4	2.2	18.9	2.3
BUN (mg/dL)n = 80 per level	Level 1	14.46	0.52	3.6	0.55	3.8
	Level 2	23.29	0.73	3.1	0.79	3.4
	Level 3	106.86	2.77	2.6	3.26	3.0
CREA (mg/dL)n = 80 per level	Level 1	1.17	0.09	8.1	0.1	8.5
	Level 2	7.52	0.32	4.3	0.32	4.3
	Level 3	15.65	0.37	2.4	0.40	2.6

Internal Precision Summary:

b. Matrix Comparison

Studies were performed using lithium heparinized venous whole blood, lithium heparinized plasma, and serum. A total of 40 human samples were analyzed by skyla Test Systems. The linear regression analyses are as follows:

	Result of Matrix Comparison

Test Item	N	Matrix	CorrelationCoefficient	Slope	Intercept
ALP	40	Serum vs. Plasma	0.9997	0.994	1.5
		Plasma vs. WB	0.9998	1.010	-2.9
		WB vs. Serum	0.9997	0.996	1.4
ALT	40	Serum vs. Plasma	0.9998	1.002	-1.3
		Plasma vs. WB	0.9998	1.005	0.00

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Test Item	N	Matrix	CorrelationCoefficient	Slope	Intercept
		WB vs. Serum	0.9997	0.993	1.2
AST	40	Serum vs. Plasma	0.9987	0.988	3.6
		Plasma vs. WB	0.9990	1.024	-7.6
		WB vs. Serum	0.9989	0.988	3.8
BUN	40	Serum vs. Plasma	0.9989	1.011	-0.45
		Plasma vs. WB	0.9988	1.008	-0.26
		WB vs. Serum	0.9990	0.982	0.71
CREA	40	Serum vs. Plasma	0.9965	0.960	0.13
		Plasma vs. WB	0.9964	1.037	0.11
		WB vs. Serum	0.9971	1.004	-0.02

c. Detection Limit

The limit of blank (LOB), limit of detection (LOD), and limit of quantitation (LOQ) were determined according to CLSI EP17. The LoB is the 95th percentile value from 60 measurements of a near zero of sample over 10 days. LoD and LoQ were performed using serum sample containing very low concentrations of the analyte to be tested in triplicate using 2 lots of reagents disc for ten days. The LoD of all analytes met the requirements for total error for each analyte, hence LoD = LoQ. The result of LoB, LoD and LoQ are summarized below table.

Analyte	LoB	LoD	LoQ
ALP (U/L)	2.350	4.405	4.405
ALT (U/L)	2.701	5.228	5.228
AST (U/L)	6.695	12.089	11.690
BUN (mg/dL)	0.795	1.526	1.526
CREA (mg/dL)	0.108	0.262	0.262

Detection Limit Summary

d. Linearity

The linearity studies of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen and creatinine were conducted in accordance to CLSI EP6. A high and low human serum pool samples were proportionally mix to create 9 intermediate dilutions that span the claimed measuring range of each analyte

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test. Some high serum pool of analytes were spiked to obtained sample that concentration range is ≥ upper claimed measuring range. The observed values were plotted against the expected values and linear regression analysis was performed. Summary results are provided in the table below.

Analyte	Tested Linearity	Regressioncoefficient (R2)	Claimed Linearity
ALP (U/L)	30 – 2083	0.9967	41 – 1500
ALT (U/L)	17 – 535	0.9999	20 – 500
AST (U/L)	16 – 1021.3	0.9984	20 – 1000
BUN (mg/dL)	1.8 – 126.9	0.9979	2 – 120
CREA (mg/dL)	0.48 – 21.48	0.9993	0.6 – 20

Linearity Summary

Interference Testing e.

Endogenous Interferences

The endogenous interferences were performed in accordance with CLSI EP07. The data demonstrated that the ALP, ALT, AST, BUN and CREA test systems were not affected by high levels of the following substances at the levels noted:

Test Item	Hemolysis[Hemoglobin]	Icterus[Bilirubin (unconjugated)]	Icterus[Bilirubin (conjugated)]
-----------	---------------------------	---------------------------------------	-------------------------------------

66.4 mg/dL

60.3 mg/dL

15.9 mg/dL

66.4 mg/dL

13.1 mg/dL

Summary of Endogenous Interferences

600 mg/dL

243 mg/dL

202 mg/dL

600 mg/dL

224 mg/dL

ALP

ALT

AST BUN

CREA

Lack of interference was defined as recoveries between 90% and 110% of the neat value, and assay performance claims were established on the skyla Clinical Chemistry Analyzer by testing two different concentrations (normal and abnormal) of the analytes (ALP, ALT, AST, BUN and CREA).

Exogenous substances

A total of 10 exogenous substances were selected as potential interferents. For each

of less than 10%

32.7 mg/dL

18.2 mg/dL

32.7 mg/dL

29.3 mg/dL

2.6 mg/dL

Lipemia

[Intralipid]

1032 mg/dL

411 mg/dL

189.9 mg/dL

1032 mg/dL

390.8 mg/dL

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potential interferent, two concentrations (low and high level) of sample were tested for the study. Significant interference is defined as a >10% shift in the test result. None of the substances at the concentration listed below significantly interfered (>10%) with ALT, ALP, AST, BUN and CREA recovery.

Substance	Test Concentration	Affected Test Item	Effect
Acetaminophen	20 mg/dL	No significant interference
Acetylsalicylic acid	65 mg/dL	No significant interference
Ampicillin	5 mg/dL	No significant interference
Ascorbic acid	6 mg/dL	No significant interference
Caffenine	6 mg/dL	No significant interference
Cephalothin	30 mg/dL	No significant interference
Cimetidine	2 mg/dL	No significant interference
Ibuprofen	50 mg/dL	CREA	11.8% Inc.
Salicylic acid	60 mg/dL	ALT	16.3% Dec.
Theophylline	4 mg/dL	ALP	14.4% Dec.

Summary of Exogenous Substances

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

Traceability: The calibrators are traceable to Siemens ADVIA Chemistry analyzer method calibration to below reference material or method. The calibration parameters of each test system were established internally, and are unique with each reagent lot. The calibration information is bar-encoded on each reagent disc. No user calibration is required.

Quality control beads are included on each reagent disk and automatically run with each assay. The information from this quality control analysis is stored with the test results and can be printed by the user. This is the internal build-in control to check fluidics, spectrophotometer, temperature, and sufficient sample delivery. In addition, sponsor recommends user to test quality controls according the federal, state, and local regulations in the labeling.

Assay	Reference material / method
ALT	The ADVIA ALT method is traceable to the IFCC reference method via patient sample correlation.
ALP	The ADVIA ALP method is traceable to the IFCC reference method via patient sample correlation.

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AST	The ADVIA AST method is traceable to the IFCC reference method viapatient sample correlation.
BUN	The ADVIA BUN method is traceable to the CDC reference method,which uses reference materials from the National Institute of Standardsand Technology (NIST). via patient sample correlation.
CREA	The ADVIA CREA_2 method is traceable to the IDMS Reference Methodvia correlation of patient samples and reference material SRM967 fromthe National Institute of Standards and Technology (NIST).

Stability: Real time stability studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. When stored at 2-8 °C the assay reagent is good until the expiration date. The shelf life of the test systems is 12 months when stored at 2-8℃.

In-use stability & Temperature/Humidity: "Temperature/Humidity Study" & "In-use stability study" have been conducted together to simulate the extremes condition and the results covered what we claimed: 1. Do not place the reagent disc at the environment more than 25℃ and longer than 48 hours prior to use. 2. Testing should be performed within 20 minutes after the pouch is opened. 3. Operation temperatures & humidity:10℃~32℃; < 95% relative humidity.

Brief Discussion of Clinical Tests Performed for Determination of Substantial 2. Equivalence are as follows:

Point-of-care (POC) Studies

Studies for method comparison and precision were performed by nine operators at three POC sites to evaluate the skyla Clinical Chemistry Analyzer with skyla's alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood urea nitrogen and creatinine test system.

POC Method comparison, whole blood and serum a.
The method comparison study was performed at three POC sites using over 120 heparinized venous whole blood and serum samples for ALT, ALP, AST, BUN and CREA test systems in comparison with comparative laboratory clinical analyzer, Beckman Coulter AU2700. Summary data is as follows:

Test Item	CorrelationCoefficient	Slope	Intercept	SEE	N	Sample range
ALP	0.9987	0.996	1.4	19.3	221	41 - 1429 U/L

Summary Result of Method Comparison, Whole blood

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Test Item	Correlation Coefficient	Slope	Intercept	SEE	N	Sample range
ALT	0.9980	1.000	0.1	8.5	185	20 – 492 U/L
AST	0.9988	0.999	1.5	15.2	174	20 – 998 U/L
BUN	0.9981	0.998	-0.14	2.01	210	2.2 – 120 mg/dL
CREA	0.9975	0.999	-0.07	0.43	190	0.6 – 19.8 mg/dL

Summary Result of Method Comparison, Serum

Test Item	CorrelationCoefficient	Slope	Intercept	SEE	N	Sample range
ALP	0.9986	1.001	3.0	20.1	221	41 - 1425 U/L
ALT	0.9983	0.994	2.4	7.6	185	20 - 493 U/L
AST	0.9986	0.996	1.8	16.2	174	20 - 997 U/L
BUN	0.9977	1.007	0.07	2.21	210	2.3 - 120 mg/dL
CREA	0.9975	1.007	-0.06	0.43	190	0.6 - 19.8 mg/dL

b. Precision studies

Precision was evaluated as described in CLSI Protocol EP5. For serum samples, three levels of human serum samples were obtained from POC sites and each level was assayed in quadruplicate twice a day for 20 days. Each of the 2 runs per day was separated by at least 4 hours. Of three levels of serum samples, two were spiked and diluted samples. The within run, total SD, and percent CVs were calculated. Summary results for precision of ALT, ALP, AST, BUN and CREA are provided in the tables below.

Serum precision, ALP & ALT
----------------------------

ALP (U/L)							ALT (U/L)
site	Sample	Mean	Within-run SD	Within-run CV (%)	TotalSD	TotalCV (%)	Mean	Within-run SD	Within-run CV (%)	TotalSD	TotalCV (%)
POC 1	Serum 1	71.9	2.3	3.20%	2.4	3.40%	40.5	2.3	5.7	2.4	5.8
	Serum 2	785.6	31.7	4.00%	32.4	4.10%	193.9	5.6	2.9	5.6	2.9
	Serum 3	1407.3	38.9	2.80%	42.3	3.00%	474.5	11.9	2.5	12.6	2.7
POC 2	Serum 1	72.2	2.1	2.90%	2.1	2.90%	40.7	2.3	5.6	2.3	5.6
	Serum 2	787	28.1	3.60%	30.1	3.80%	192.3	5.0	2.6	5.4	2.8
	Serum 3	1405.1	20.5	1.50%	25.9	1.80%	477.2	9.8	2.0	10.8	2.3
POC 3	Serum 1	71.9	1.7	2.30%	1.7	2.30%	40.6	2.0	5.0	2.2	5.3
	Serum 2	784.1	27.1	3.50%	32.8	4.20%	194.8	5.9	3.0	6.7	3.4

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	Serum 3	1405.9	37.5	2.70%	478.2	14.8	3.1
	Serum 1	72.0	1.8	2.56%	40.6	2.0	5.0
All	Serum 2	785.5	29.3	3.73%	193.6	5.8	3.0
	Serum 3	1406.0	33.3	2.36%	476.7	12.3	2.6

Serum precision, AST & BUN

				AST (U/L)			BUN (mg/dL)
site	Sample	Mean	Within-run SD	Within-run CV (%)	TotalSD	TotalCV (%)	Mean	Within-run SD	Within-run CV (%)	TotalSD	TotalCV (%)
POC 1	Serum 1	40.3	2.9	7.3%	3.1	7.6%	14.43	0.48	3.3	0.50	3.5
	Serum 2	283.5	4.7	1.6%	5.0	1.8%	23.43	0.78	3.3	0.78	3.3
	Serum 3	842.5	13.8	1.6%	13.9	1.6%	106.67	3.14	2.9	3.57	3.4
POC 2	Serum 1	40.1	3.3	8.2%	3.4	8.6%	14.59	0.43	3.0	0.49	3.4
	Serum 2	279.7	5.6	2.0%	5.8	2.1%	23.36	0.88	3.8	0.94	4.0
	Serum 3	839.6	10.0	1.2%	11.7	1.4%	106.35	2.53	2.4	3.37	3.2
POC 3	Serum 1	40.0	2.93	7.3%	3.4	8.4%	14.52	0.46	3.1	0.49	3.4
	Serum 2	286.0	5.5	1.9%	7.2	2.5%	23.40	0.86	3.7	0.94	4.0
	Serum 3	843.3	16.3	1.9%	16.5	2.0%	105.82	3.12	2.9	3.40	3.2
	Serum 1	40			2.9	7.3%	14.51			0.48	3.3
All	Serum 2	283			6.2	2.2%	23.40			0.81	3.5
	Serum 3	841			14.3	1.7%	106.28			3.29	3.1

Serum precision, CREA

		CREA (mg/dL)
site	Sample	Mean	Within-run SD	Within-run CV (%)	TotalSD	TotalCV (%)
POC 1	Serum 1	0.97	0.06	5.8%	0.07	7.0%
	Serum 2	7.36	0.25	3.3%	0.25	3.4%
	Serum 3	15.75	0.35	2.2%	0.36	2.3%
POC 2	Serum 1	1.28	0.08	6.4%	0.09	6.8%
	Serum 2	7.62	0.22	2.9%	0.25	3.2%
	Serum 3	15.62	0.45	2.9%	0.48	3.1%
POC 3	Serum 1	1.07	0.07	6.7%	0.07	6.8%
	Serum 2	7.36	0.27	3.7 %	0.30	4.0 %
	Serum 3	15.45	0.41	2.7 %	0.46	3.0 %
All	Serum 1	1.11			0.10	7.0%
	Serum 2	7.45			0.27	3.7%
	Serum 3	15.60			0.43	2.8%

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		ALP (U/L)			ALT (U/L)			AST(g/dL)			BUN (mg/dL)
Site	operator	Sample level	Average	SD	CV	Average	SD	CV	Average	SD	CV	Average	SD	CV
POC-1	OP1	Low	56.9	2.51	4.42%	28	2.7	9.7%	32	2.7	8.60%	11.0	0.24	2.2%
	OP2	Low	75.9	2.64	3.48%	30	2.2	7.5%	29	1.9	6.40%	10.9	0.21	2.0%
	OP3	Low	99.4	2.91	2.93%	31	2.5	8.1%	31	2.9	9.30%	10.5	0.36	3.5%
POC-1	OP1	Medium	744.9	12.06	1.62%	294	4.1	1.4%	459	6.4	1.40%	30.9	0.72	2.3%
	OP2	Medium	781.6	12.69	1.62%	294	3.4	1.2%	459	5.4	1.20%	31.1	0.88	2.8%
	OP3	Medium	677.9	8.88	1.31%	298	6.5	2.2%	455	13.1	2.90%	30.6	1.18	3.9%
POC-1	OP1	High	1341	10.84	0.81%	402	6.6	1.6%	814	3.2	0.40%	93.7	3.06	3.3%
	OP2	High	1312.6	13.13	1.00%	397	12.9	3.2%	801	1.6	0.20%	92.3	2.96	3.2%
	OP3	High	1405.8	18.27	1.30%	401	9.8	2.4%	798	3.6	0.50%	93.8	2.77	3.0%
POC-2	OP1	Low	61.5	3.57	5.80%	37	1.0	2.8%	32	2.2	6.70%	10.7	0.33	3.1%
	OP2	Low	68.5	2.84	4.14%	37	1.3	3.6%	28	2.2	7.80%	10.5	0.32	3.0%
	OP3	Low	101	2.54	2.51%	37	1.1	2.9%	33	2.6	8.10%	10.3	0.20	1.9%
POC-2	OP1	Medium	749.9	15.79	2.11%	228	3.2	1.4%	105	6.5	6.20%	16.1	0.45	2.8%
	OP2	Medium	766.5	10.83	1.41%	230	4.5	2.0%	102	6.4	6.30%	16.2	0.42	2.6%
	OP3	Medium	665	10.02	1.51%	230	7.9	3.4%	104	7.9	7.60%	16.1	0.65	4.0%
POC-2	OP1	High	1322.5	11.33	0.86%	397	9.8	2.5%	818	15.8	1.90%	111.0	2.98	2.7%
	OP2	High	1311.5	18.92	1.44%	401	9.6	2.4%	833	15.8	1.90%	110.5	4.78	4.3%
	OP3	High	1419.3	9.87	0.70%	408	10.8	2.6%	841	11.2	1.30%	110.1	4.11	3.7%
POC-3	OP1	Low	61.9	2.69	4.34%	41	3.3	8.1%	41	2.1	5.00%	7.4	0.33	4.5%
	OP2	Low	66	3.97	6.02%	39	1.2	3.0%	38	2.9	7.70%	7.4	0.29	3.9%
	OP3	Low	106.5	3.5	3.29%	41	3.9	9.4%	41	1.4	3.50%	7.4	0.23	3.1%
	OP1	Medium	757.7	13.57	1.79%	219	9.5	4.3%	265	8.3	3.10%	29.0	1.03	3.6%
	OP2	Medium	767.7	13.32	1.73%	224	5.3	2.3%	279	3.6	1.30%	29.1	0.68	2.3%
POC-3	OP3	Medium	682	4.67	0.68%	225	5.6	2.5%	273	9	3.30%	28.2	1.05	3.7%
	OP1	High	1315.1	17.22	1.31%	476	8.9	1.9%	844	8.4	1.00%	91.4	3.98	4.4%
	OP2	High	1330	16.05	1.21%	480	14.9	3.1%	851	18.8	2.20%	93.8	3.30	3.5%
POC-3	OP3	High	1398.4	19.68	1.41%	481	9.1	1.9%	851	16.4	1.90%	94.7	4.02	4.2%

Whole Blood precision, ALP, ALT, AST, BUN

Whole Blood precision, CREA

Site	operator	Sample level	CREA (mg/dL)
			Average	SD	CV
POC-1	OP1	Low	0.9	0.05	5.5%
			CREA (mg/dL)
Site	operator	Sample level	Average	SD	CV
	OP2	Low	0.9	0.07	7.4%
	OP3	Low	0.9	0.07	7.3%
	OP1	Medium	7.7	0.17	2.2%
	OP2	Medium	7.6	0.27	3.5%
	OP3	Medium	7.6	0.45	5.9%
	OP1	High	16.5	0.6	3.6%
	OP2	High	16.6	0.62	3.8%
	OP3	High	16.6	1.05	6.3%
			CREA (mg/dL)
Site	operator	Sample level	Average	SD	CV
	OP1	Low	0.8	0.05	6.8%
	OP2	Low	0.7	0.04	5.9%
	OP3	Low	0.8	0.05	6.3%
	OP1	Medium	3.6	0.17	4.8%
POC-2	OP2	Medium	3.7	0.16	4.4%
	OP3	Medium	3.9	0.27	6.9%
	OP1	High	16.4	0.63	3.8%
	OP2	High	15.8	0.56	3.5%
	OP3	High	16.1	0.68	4.2%
POC-3	OP1	Low	0.8	0.05	7.0%
	OP2	Low	0.7	0.05	7.0%
	OP3	Low	0.7	0.04	5.9%
	OP1	Medium	4.7	0.14	3.0%
	OP2	Medium	4.6	0.22	4.7%
	OP3	Medium	4.8	0.33	6.8%
	OP1	High	14	0.75	5.3%
	OP2	High	14.1	0.62	4.4%
	OP3	High	14.4	0.93	6.5%

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Study results indicate precision with %CV less than 10% between operators on all test systems at three levels of concentration.

3. Electrical safety and electromagnetic compatibility (EMC)

The tests have been performed by the accredited laboratories and show full

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compliance with the IEC standard. The device under consideration has passed the tests according to IEC 60601-1-2.

VIII. CONCULSIONS

The clinical and non-clinical tests performed for alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen and creatinine, when run on the subject Clinical Chemistry Analyzer with Comprehensive Metabolic Panel, demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device identified above.

Regulation Number and Section

§ 862.1050 Alkaline phosphatase or isoenzymes test system.

(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.