Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard photometric measurement technology and chemical reactions, with no mention of AI or ML.

Therapeutic

No.

The device is an in-vitro diagnostic device used for quantitative determination of clinical chemistry analytes to assist in the diagnosis and treatment of diseases. It does not directly provide therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the Comprehensive Metabolic Panel, the skyla Clinical Chemistry Analyzer, and the Minicare C300 Clinical Analyzer are "intended to be used for the quantitative determination of [various substances]... in the diagnosis and treatment of [various diseases]". This directly indicates a diagnostic purpose. Additionally, the text refers to the skyla and Minicare C300 Clinical Analyzers as "in-vitro diagnostic devices".

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of a portable analyzer (hardware) and single-use disposable reagent panel discs (hardware/consumable). It also describes the analyzer's use of photometric measurement technology and the reagent disc's function in separating blood and mixing with reagents, all of which are hardware-dependent processes.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states the device 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". These are all biological samples taken in vitro (outside the body). The intended use is for "diagnosis and treatment" of various diseases, which is a key characteristic of IVDs.
Device Description: The description details how the device analyzes "blood" and measures "substance in blood" using photometric measurement technology and reagent discs. This process is performed in vitro.
Explicit Statements: The document contains multiple explicit statements identifying the device as an IVD:
- "The skyla Clinical Chemistry Analyzer is an in-vitro diagnostic device..."
- "The Minicare C300 Clinical Analyzer is an in-vitro diagnostic devices..."
- "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." (Clinical laboratories and point-of-care locations are typical settings for IVD use).

The entire description and intended use clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 (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.

Product codes

CJE, CKA, CDN, CGX, CIT, JJG

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 convert 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratory setting or point-of-care location.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests:

Internal precision/ Reproducibility:
- Study Type: Precision study following CLSI EP5 guidelines.
- Sample Size: 80 runs for each level (quadruplicate a day for 20 working days).
- Key Results: All six test systems showed good precision with %CV being less than 10% for three different levels of patient serum samples.
Matrix Comparison:
- Study Type: Comparison study.
- Sample Size: 40 human samples analyzed.
- Data Source: Lithium heparinized venous whole blood, lithium heparinized plasma, and serum.
- Key Results: High correlation coefficients (ranging from 0.9964 to 0.9998) between serum, plasma, and whole blood for all analytes, indicating good agreement across matrices.
Detection Limit:
- Study Type: Detection limit determination according to CLSI EP17.
- Data Source: Near zero sample for LoB; serum sample with very low concentrations for LoD and LoQ; 2 lots of reagents disc.
- Key Results: LoD of all analytes met the requirements for total error, and LoD = LoQ.
Linearity:
- Study Type: Linearity studies according to CLSI EP6.
- Data Source: High and low human serum pool samples mixed proportionally to create 9 intermediate dilutions. Some high serum pool of analytes were spiked.
- Key Results: High regression coefficients (R2 ranging from 0.9967 to 0.9999) indicating linearity within or beyond the claimed measuring ranges for all analytes.
Interference Testing (Endogenous Interferences):
- Study Type: Endogenous interference study in accordance with CLSI EP07.
- Key Results: ALP, ALT, AST, BUN, and CREA test systems were not affected by high levels of Hemolysis (Hemoglobin), Icterus (Bilirubin (unconjugated/conjugated)), or Lipemia (Intralipid), defined as recoveries between 90% and 110% of the neat value.
Interference Testing (Exogenous substances):
- Study Type: Exogenous interference study.
- Key Results: None of the tested substances significantly interfered (>10% shift) with ALT, ALP, AST, BUN, and CREA recovery, except for Ibuprofen (11.8% Inc. for CREA), Salicylic acid (16.3% Dec. for ALT), and Theophylline (14.4% Dec. for ALP).
Traceability, Stability, Expected values:
- Study Type: Traceability and Stability studies.
- Traceability: Calibrators traceable to Siemens ADVIA Chemistry analyzer method calibration or reference methods/materials (IFCC, CDC, NIST, IDMS).
- Stability: Shelf life of 12 months at 2-8°C. In-use stability and temperature/humidity studies performed to cover claimed conditions (do not place reagent disc at >25°C for >48 hours; testing within 20 minutes after pouch opened).

Clinical Tests:

Point-of-care (POC) Studies:
- Study Type: Method comparison and precision studies.
- Performed By: Nine operators at three POC sites.
POC Method comparison, whole blood and serum:
- Study Type: Method comparison.
- Sample Size: Over 120 heparinized venous whole blood and serum samples for each analyte.
- Comparative Device: Beckman Coulter AU2700.
- Key Results (Whole Blood): High correlation coefficients (0.9975 to 0.9988) and slopes near 1 (0.996 to 1.000) for all analytes.
- Key Results (Serum): High correlation coefficients (0.9975 to 0.9986) and slopes near 1 (0.994 to 1.007) for all analytes.
Precision studies (Serum):
- Study Type: Precision study following CLSI Protocol EP5.
- Sample Size: Three levels of human serum samples from POC sites, assayed in quadruplicate twice a day for 20 days.
- Key Results: Within run, total SD, and percent CVs were calculated for ALP, ALT, AST, BUN, and CREA at three levels across three POC sites. Total CVs for all analytes and levels were generally low (e.g., ALP: 2.36%-3.73%; ALT: 2.6%-5.0%; AST: 1.7%-7.3%; BUN: 3.1%-3.5%; CREA: 2.8%-7.0%).
Precision studies (Whole Blood):
- Study Type: Precision study (implied similar to serum precision, with operator variability across POC sites).
- Key Results: Study results indicate good precision with %CV less than 10% between operators on all test systems at three levels of concentration.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found (beyond precision metrics like %CV and correlation coefficients described in performance studies)

Predicate Device(s)

K942782, K950164

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

1

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

2

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)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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, Hsinchu
30078, 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 | Product
Code | Regulation number/
Class |
|-------------------------------------------------------|-----------------|---------------------------------------|
| Analyzer, chemistry, centrifugal, for clinical use | JJG | 862.2140/ Class I, 510(k)
exempt* |
| Alanine amino transferase (ALT/SGPT) test
system | CKA | 862.1030/ Class I |
| Alkaline phosphatase or isoenzymes test system | CJE | 862.1050/ Class II |
| Aspartate amino transferase (AST/SGOT) test
system | 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 Chemistry
Analyzer	PiccoloTM	Abaxis, Inc.	K942782
Comprehensive
Metabolic Panel	Comprehensive
Metabolic Panel	Abaxis, Inc.	K942782
K950164

IV. 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.

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

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.

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 Analyzer
skyla / Minicare C300 | Predicate Device
K942782 |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | 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. | Point-of-Care,
quantitative
of
determination
clinical
chemistry
analytes
in
heparinized
whole
blood,
heparinized plasma, or serum. |
| Light source | LEDs | Xenon arc stroboscopic lamp |
| Detector | Photodiode | Same |
| Height x Width
x Depth | Skyla: 300 x 223 x 285 mm
Minicare: 200 x 185 x 262 mm | 242 x 153 x 292mm |
| Test time | 15 min. | 12 min. |
| Method
of
measurements | Colorimetry (Absorbance) | Same |
| Liquid handling | Centrifugation technology | Same |
| Blood
separation
function | Integrated in the device | Same |
| Testing
environment | Clinical laboratory, point-of-care | Same |
| Assay
temperature | 37°C (98.6°F) | Same |
| Power
requirement | 100-240 volts AC; 50-60 Hz; or 12
volts DC, 5.0A | 100-240 volts AC; 50-60 Hz;
or 15 volts DC, 5.0A |
| Electromagnetic
compatibility
electrical
and
safety | IEC 60601-1-2 | Same |
| Operating
Temperature | 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: CKA
ALP: CJE
AST: CIT
BNU: CDN
CREA: 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 nm
ALP: 405 nm
AST: 340 nm
BUN: 340 nm
CREA: 546 nm | ALT: 340 - 405 nm
ALP: 405 - 500 nm
AST: 340 - 405 nm
BUN: 340 - 405 nm
CREA: 550 nm - 600 nm |
| Detection Limit | ALT: 2.350 U/L
ALP: 4.405 U/L
AST: 6.695 U/L
BUN: 1.526 mg/dL
CREA: 0.262 mg/dL | ALT: 5 U/L
ALP: 5 U/L
AST: 5 U/L
BUN: 2.0 mg/dL
CREA: 0.2 mg/dL |
| Reportable Range | ALT: 20 - 500 U/L
ALP: 41 - 1500 U/L
AST: 20 - 1000 U/L
BUN: 2 – 120 mg/dL
CREA: 0.6 – 20 mg/dL | ALT: 5 - 2000 U/L
ALP: 5 - 2400 U/L
AST: 5 - 2000 U/L
BUN: 2 – 180 mg/dL
CREA: 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 | Correlation
Coefficient | 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 | Correlation
Coefficient | 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 | Regression
coefficient (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:

-----------	---------------------------	---------------------------------------	-------------------------------------

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 via
patient sample correlation. |
|------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BUN | The ADVIA BUN method is traceable to the CDC reference method,
which uses reference materials from the National Institute of Standards
and Technology (NIST). via patient sample correlation. |
| CREA | The ADVIA CREA_2 method is traceable to the IDMS Reference Method
via correlation of patient samples and reference material SRM967 from
the 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℃;