The XL-200 Clinical Chemistry Analyzer is an automated random access, computer controlled, bench top, clinical analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. This device is intended for clinical laboratory use.

The JAS Glucose Reagent is intended for the in vitro quantitative measurement of glucose in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use. 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.

The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, and chloride concentrations in serum on the XL-200 clinical chemistry analyzer. This device is intended for clinical laboratory use.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Device Description

The XL-200 Clinical Chemistry Analyzer is an automated bench top, random access, open analyzer for clinical chemistry and immunoturbidimetric analysis on serum, urine, and other body fluids. The analyzer mainly uses colorimetric, turbidimetric, and ion selective electrode methods for analysis of samples.

The instrument includes of the following main parts;

. Sampling Arm (for sample addition to cuvettes)
Reagent Arm (for reagent addition to cuvettes) .
Reaction Station (cuvettes) .
Sample Plate Station (for loading samples) .
Reagent Plate Station (for on board reagents) .
. Photometer (for reaction analysis reading)
Wash Station (for cleaning of reaction cuvettes) .
Electronic Boards (for controlling the open functions) .

The JAS Glucose Reagent is intended for the quantitative measurement of glucose in serum on the XL-200 Clinical Chemistry Analyzer. The Reagent is a single vial liquid that is placed for use on the XL-200 Clinical Chemistry Analyzer reagent carousel. The reagent uses the enzymatic (Hexokinase/G-6-P) UV (340nm) method. This device is for clinical laboratory use.

The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the JAS XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, and ISE Reagent Pack, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials. Therefore, information regarding human reader studies (MRMC), standalone AI performance, and expert qualifications for ground truth in the traditional sense of AI/ML studies are not typically found in these submissions as the device is not an AI/ML diagnostic tool. The "ground truth" here refers to established, validated reference methods or materials in clinical chemistry.

1. Table of Acceptance Criteria and Reported Device Performance

Device: XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack
Tests: Glucose, Sodium, Potassium, Chloride

Performance Characteristic	Acceptance Criteria (Implicit from Results)	Reported Device Performance (Glucose)	Reported Device Performance (Sodium)	Reported Device Performance (Potassium)	Reported Device Performance (Chloride)
Linearity	Data linear within allowable nonlinearity (e.g., 3mg/dL or 5%)	9 to 500 mg/dL	100 to 200 mEq/L	1.0 to 10.0 mEq/L	50 to 150 mEq/L
	Slope between 0.90 and 1.10	1.001 (Glucose linearity)	-	-	-
	Intercept close to 0 mg/dL	-0.1 mg/dL (Glucose linearity)	-	-	-
Calibrator Traceability Accuracy	"Accuracy test passed and results linear" with acceptable slope and intercept.	Slope: 0.972, Intercept: 2.1mg/dL, Error: 1.4%	Slope: 1.007, Intercept: 4.4mmol/L, Error: 0.1%	Slope: 0.902, Intercept: 0.1mmol/L, Error: 1.3%	Slope: 1.012, Intercept: 2.0mmol/L, Error: 1.3%
Interferences	Glucose values remain within 10% of unspiked sample value.	Hemoglobin: up to 400 mg/dLBilirubin: up to 21.4 mg/dLLipemia: up to 412 mg/dLAscorbic Acid: up to 10.0 mg/dL	Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL	Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL	Hemolyzed samples should not be usedLipemia: up to 1084 mg/dL*Bilirubin: up to 22.5 mg/dL
Method Comparison (Correlation)	R > 0.95, Slope between 0.90 and 1.10, Intercept close to 0	R: 0.9970, Slope: 1.002, Intercept: 1.8 mg/dL (vs. Olympus 400 Glucose Reagent)	R: 0.9917, Slope: 0.984, Intercept: 2.256 mmol/L (vs. Olympus 400 ISE)	R: 0.9954, Slope: 0.999, Intercept: 0.05 mmol/L (vs. Olympus 400 ISE)	R: 0.9856, Slope: 1.070, Intercept: -4.3 mmol/L (vs. Olympus 400 ISE)
Precision/ Reproducibility (CV%)	CV (%) < 5% for both within run and total precision.	Within Run: Level 1: 1.7%, Level 2: 1.2%, Level 3: 1.2%Total: Level 1: 2.6%, Level 2: 1.8%, Level 3: 1.3%	Within Run: Level 1: 0.3%, Level 2: 0.3%, Level 3: 0.5%Total: Level 1: 0.7%, Level 2: 0.8%, Level 3: 0.8%	Within Run: Level 1: 1.9%, Level 2: 0.3%, Level 3: 0.6%Total: Level 1: 2.1%, Level 2: 0.8%, Level 3: 1.1%	Within Run: Level 1: 0.5%, Level 2: 0.6%, Level 3: 0.3%Total: Level 1: 0.8%, Level 2: 0.7%, Level 3: 0.5%

2. Sample size used for the test set and the data provenance

Glucose Correlation (Test Set): 103 sample pairs (serum), multiple days, various glucose levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Sodium Correlation (Test Set): 101 sample pairs (serum), multiple days, various analyte levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Potassium Correlation (Test Set): 90 sample pairs (serum), multiple days, various analyte levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Chloride Correlation (Test Set): 88 sample pairs (serum), multiple days, various analyte levels.
- Data Provenance: Not explicitly stated, but clinical laboratory use is mentioned, suggesting human serum samples. The testing was comparative against a predicate device.
Precision (Test Set): Three glucose, sodium, potassium, and chloride sample levels, each run 20 times in duplicate over 20 days.
- Data Provenance: In-house laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a clinical chemistry analyzer, not an image-based diagnostic AI/ML device requiring expert interpretation for ground truth. The "ground truth" for the test set is established by the measurements from the predicate device (Olympus AU400 Clinical Chemistry Analyzer) or by reference materials/methods (e.g., Verichem Laboratories Matrix Plus Chemistry Reference Kit, NIST-traceable materials).

4. Adjudication method for the test set

Not applicable. As this is a clinical chemistry device, adjudication in the sense of reconciling human expert opinions is not relevant. The comparison is between the device's measurements and those of a predicate device/reference standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML diagnostic device involving human readers.

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

Yes, the studies presented are for the standalone performance of the device (XL-200 Analyzer with its reagents). The device itself performs the quantitative measurements without human-in-the-loop diagnostic interpretation of results in the context of an AI/ML algorithm. The results are reported as numerical values.

7. The type of ground truth used

The ground truth for the performance studies is primarily established by:

Predicate Device Measurements: For correlation studies, the measurements from the legally marketed Olympus AU400 Clinical Chemistry Analyzer (using Olympus reagents) served as the reference standard.
Reference Materials: For calibrator traceability studies, Verichem Laboratories Matrix Plus Chemistry Reference Kit (9500), verified and lot certified using National Institute of Standards and Technology (NIST) traceable standard reference materials, was used.
Theoretically Prepared Standards: For linearity studies, serial dilutions of stock standards with known concentrations were used.
Established Analytical Methods: The hexokinase/G-6-P enzymatic method for glucose and ion-selective electrodes for electrolytes are well-established analytical principles in clinical chemistry.

8. The sample size for the training set

Not applicable. This device is a traditional clinical chemistry analyzer and reagent system, not an AI/ML device that requires a "training set" in the machine learning sense. The device's performance characteristics (e.g., linearity, precision, interference) are determined to define its operating range and robustness, not to train an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device. The ground truth for validating the device's performance is established as described in point 7.

Summary

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1 5 2014

510(k) Summary

1.) Safety and effectiveness as required by 21 CFR 807.92 STATEMENT

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807,92.

2.) Submitter's / Owner of the 510(k) and Contact Information

Name: JAS Diagnostics

Address: 14100 N.W. 57th Court Miami Lakes, FL 33014

Phone: 305 418-2320 Fax: 305 418-2321

Official Correspondent David Johnston

E-mail: djohnston@jasdiagnostics.com

Date of Preparation April 14, 2014

510(k) Application Number K130915

3.) 510k Number, Device, Proprietary Name, Common Name, Purpose for Submission, Regulatory Classification, Panel, Product Code And CFR Number

Regulation Number:	Device Description
21CFR Sec. - 862.2160	Discrete Photometric Chemistry Analyzer for Clinical Use
21CFR Sec. - 862.1345	Glucose Test System
21CFR Sec. - 862.1665	Sodium Test System
21CFR Sec. - 862.1600	Potassium Test System
21CFR Sec. - 862.1170	Chloride Test System

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MOT A : YAM

Classifications:

Class II and Class I (Analyzer)

Product Codes

JJE Analyzer, Chemistry (Photometric, Discrete), for Clinical Use
CFR Hexokinase, Glucose

JGS - Electrode, Ion Specific, Sodium

CEM - Electrode, Ion Specific, Potassium

CGZ Electrode, Chloride

Panel

Chemistry (75)

4.) Proprietary Name and Common Name

Trade/Proprietary Name

XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack

Common Name/Usual Name

XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack

5.) Indications for Use

The XL-200 Clinical Chemistry Analyzer is an automated, random access. computer controlled, bench top clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium, and chloride in serum. This device is intended for clinical laboratory use.

The JAS Glucose Reagent in intended for the in vitro quantitative measurement of glucose in serum on the XL-200 Clinical Chemistrv Analyzer. This device is intended for clinical laboratory use. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.

The ISE Reagent Pack is intended for the in vitro quantitative measurement of sodium, potassium, and chloride concentrations in serum on the XL-200 Clinical Chemistry Analyzer. This device is intended for clinical laboratory use.

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.

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Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

6.) Device Description: JAS XL-200 Clinical Chemistry Analyzer

The instrument includes of the following main parts;

. Sampling Arm (for sample addition to cuvettes)
Reagent Arm (for reagent addition to cuvettes) .
Reaction Station (cuvettes) .
Sample Plate Station (for loading samples) .
Reagent Plate Station (for on board reagents) .
. Photometer (for reaction analysis reading)
Wash Station (for cleaning of reaction cuvettes) .
Electronic Boards (for controlling the open functions) .

7.) Substantial Equivalence Information:

1.) Predicate 510(k) number: K981743
2.) Olympus AU400 Clinical Chemistry Analyzer:
3.) Comparison to predicate:

	Device Name	Device:XL-200Clinical ChemistryAnalyzer	Predicate Device:OLYMPUS AU400Clinical ChemistryAnalyzer
1	510(k)	Pending	K981743

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2	System Principles
	QC/Calibration	Automatic and Manual	Automatic and Manual
	LIS external connectivity	YES	YES
	Barcode	Samples	Samples
		Reagents	Reagents
	Re-dilution on abnormals	YES	YES
3	Throughput	200 test/hour	400 test/hour
		400 with ISE	800 with ISE
4	Principle of analysis
	Mode of detection	Photometric / ISE	Photometric / ISE
	Analytical Methods	Endpoint, Kinetic, IonSelective Electrodes	Endpoint, Kinetic, IonSpecific Electrodes
	Calibration	Linear and non linear	Linear and non linear
5	Opticalmeasurement unit
	Measurement modes	Absorbance	Absorbance
	Optical modes	Bichromatic,turbidimetric	Bichromatic, turbidimetric
	Wavelengths	340nm, 405nm,505nm, 546nm,578nm, 600nm,660nm, 700nm	340nm, 380nm, 410nm,450 nm, 480nm, 520nm,540nm, 570nm, 600nm,660nm , 700nm, 750nm800nm
	Linear absorbance range	0.0 to 2.5 A	0 to 2.5 A
	Light source	halogen lamp	halogen lamp
	Detector	Silicone photodiodearray	Silicon photodiodes

6	Reaction unit
	Reaction cuvettes	45 quartz semi-disposable	88 quartz semi-disposable
	Reaction volume	180 to 570 uL	180 to 610 uL
	Path length	Calculated at 10mm	10mm conversion
	Temperature	Room, 30°C, 37°C	Room, 30°C, 37°C
7	Sample andreagent unit
	Reagent positions	25 for Rgt1, 50mLbottles25 for Rgt2, 20mLbottles	38 for Rgt1, 60mL bottles38 for Rgt2, 15 & 30mLbottles
	Sample positions	39	48
	Pipetter system	plunger, stepper motordriven	Micro-syringe, motordriven
	Mixing	Immersion mixing byrotating mixers	Rotating mix bar
	Reagent refrigeration	YES	YES
	Sample dispensing	2 - 70 microliters	2 - 50 microliters
8	Power	AC220V. 50 Hz or110v, 60Hz	AC210V, 60Hz (U.S.)
9	Environmental	15 to 30°C,Humidity 40 to 80%	15 to 30°C,Humidity 40 to 80%
	conditions	Humidity 40 to 80%	Humidity 40 to 80%

10	ISE Principle	Ion selective, directmeasurement	Ion selective, directmeasurement
11	ISE sample type	Serum	Serum, Urine
12	Available tests	Na, K, Cl	Na, K, Cl
13	ISE calibration	Two-point and single point	Two-point and single point
14	Sample size	70 uL	70 uL

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8.) Device Description: JAS Glucose Reagent

9.) Substantial Equivalence Information:

Predicate 510(k) number: K981743

Olympus AU400 Clinical Chemistry Analyzer, Glucose Reagent

10.) Comparison to predicate:

Manufacturer:	JAS Diagnostics	Beckman Coulter Olympus
Device Name	JAS Glucose Reagent forXL-200 ClinicalChemistry Analyzer	Olympus Glucose Reagent forOlympus AU 400 & 600series Chemistry Analyzers
	JAS Diagnostics	Beckman Coulter (Olympus)
FDA 510k #	K130915 (CFR)(Pending)	K981743 (CFR)
Classification	Moderate(Pending)	Moderate

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Intended Use	quantitative measurementof glucose in serumon the XL-200 ClinicalChemistry analyzerFor clinical laboratory use	quantitative measurementof glucose in serum, plasmaurine, on Beckman Coulterclinical chemistry analyzersFor clinical laboratory use
Methodology	enzymatic (Hexokinase /G-6-P), UV (340nm)	enzymatic (Hexokinase /G-6-P), UV (340nm)
Reagent Description	Single vial liquid reagent	Two vial liquid reagent
Normal RangeAdult	74 - 106 mg/dL	70 - 105 mg/dL

11.) Performance Characteristics - Glucose .

Linearity

Protocol: 9 Serial Dilutions of a 500 mg/dL Glucose Standard were prepared and run on the XL-200, along with the 500 mg/dL stock Standard. Results were then plotted as a regression graph against theoretical recovery.

Results: Acceptable Slope 1.001 and Intercept of -0.1mg/dL, and data linear within allowable nonlinearity of 3mg/dL or 5% resulted; validating the product's claimed linearity range of 9 to 500mg/dL.

Calibrator Traceability:

Protocol: Verichem Laboratories Matrix Plus Chemistry Reference Kit (9500) five level reference material was run on the XL-200 Clinical Chemistry Analyzer, using JAS Glucose Reagent. This material is "Verified and lot certified using available standard reference materials for the National Institute of Standards and Technology (NIST)."

Results:

Program's Evaluation of glucose Results states accuracy test passed and results linear; with a slope of 0.972 and intercept of 2.1mg/dL, with error of 1.4%.

Interferences

Protocol: Serial dilutions were prepared using a high interferent sample material, with the same sample material (glucose level) without the interferent spiked. Acceptable interference level is the is the highest interferent sample level were the glucose values remains within 10% of the sample value unspiked with the intereferent.

Results: The following highest interferent levels for the sample, with < 10% interferent were obtained.

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Hemoglobin	up to 400 mg/dL
Bilirubin	up to 21.4 mg/dL
Lipemia	up to 412 mg/dL
Ascorbic Acid	up to 10.0mg/dL

Correlation

Protocol: Multiple serum samples, at various glucose levels, were run on multiple days through the test's analytical range on the XL-200 clinical chemistry analyzer, using JAS Glucose reagent and also on the Olympus 400, using Olympus Glucose reagent. Results were compared using a correlation plot.

Results: The following acceptable statistics resulted, i.e. R > 0.95, Slope between 0.90 and 1.10, and intercept close to 0 mg/dL level.

JAS Glucose reagent on the XL-200 Clinical Chemistry Analyzer versus Olympus glucose reagent of Olympus 400:

Number of sample pairs:	103
Range tested: x method	11 to 497 mg/dL
y method	9 to 501 mg/dL
Corr. Coef. (R)	0.9970
Slope	1.002
Intercept	1.8 mg/dL

Precision/Reproducibility:

Protocol: Precision was performed using "EP Evaluator's NCCLS EP5-T2 Precision document (NCCLS.EP5)" program. Three glucose sample levels were run 20 times in duplicate, using 20 runs over a 20 day period on the XL-200 Clinical Chemistry Analyzer, for within run and for total imprecision calculation/determination.

Results: Results were entered into Rhoads EP Evaluator Software for determining precision S.D. and CV levels. All results below meet requirement of CV (%) < 5% for both within and total precision.

Glucose
Within Run	Level 1	Level 2	Level 3
Mean (mg/dL)	49.8	96.2	303.4
S.D. (mg/dL)	0.9	1.1	3.6
C.V. (%)	1.7	1.2	1.2
Total
S.D. (mg/dL)	1.3	1.8	3.8
C.V. (%)	2.6	1.8	1.3

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12.) Device Description: ISE Reagent Pack (for use on the XL-200 Clinical Chemistry Analyzer)

		XL-200Clinical ChemistryAnalyzer	Beckman Coulter OlympusAU400
1	ISE Principle	Ion selective, directmeasurement	Ion selective, directmeasurement
2	ISE sample type	Serum	Serum, Urine
3	Available tests	Na, K, Cl	Na, K, Cl
4	ISE calibration	Two-point and singlepoint	Two-point and single point
5	Sample size	70 uL	70 uL

Comparison to Beckman Coulter Olympus 400:

Device Description: The JAS ISE Module consists of ion selective electrodes for sodium, potassium, and chloride, a reference electrode and accessory reagents.

XL-200 Clinical Chemistry Analyzer ISE Solutions:

*ISE Reagent Pack: REF: 5423-0030: Calibrant A, 520mL: (Na 140.0, K 4.00, Cl 125.0 mmol/L)

Calibrant B, 190mL: (Na 70.0, K 8.00, Cl 41.0 mmol/L)

*REF 5421 Cleaning Solution

Beckman Coulter Olympus ISE Solutions:

ISE Buffer, PN: AUH1011 ISE Reference, PN: AUH1013 ISE Mid Standard, PN: AUH1012

Internal Reference Solution, PN: AUH1017 ISE Low Standard, PN: 1014 ISE High Standard, PN: 1015 Na Selectivity Check, PN: AUH1018

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XL-200 Clinical Chemistry Analyzer; Electrodes: *REF 5201: Na Electrode *REF 5202: K Electrode *REF 5207: Cl Electrode *REF 5204: Reference Electrode

14.) Substantial Equivalence Information for ISE Reagent Pack:

1.) Predicate 510k number: K981743

2.) Manufacturer: Beckman Coulter (Olympus)
3.) Comparison to predicate: See below comparison.

Device Name	JASISE Reagent Pack forXL-200 Clinical ChemistryAnalyzer	OLYMPUSISE Reagents forOlympus AU 400 & 600series chemistry analyzers
Manufacturer	JAS Diagnostics	Beckman Coulter (Olympus)
FDA 510k #	K130915(Pending)	K981743
	JAS	OLYMPUS
Classification	Moderate(Pending)	Moderate
Intended Use	quantitative measurementof sodium, potassium andchloride concentrationsin serum on the XL-200clinical chemistryanalyzer.For clinical laboratory use	quantitative measurementof sodium, potassium andchloride in serum and urineon Beckman Coulterclinical chemistry analyzers.For clinical laboratory use
Methodology	Ion Selective Electrodes(ISEs)	Ion Selective Electrodes(ISEs)
Reagent Description	ISE Reagent Pack:Calibrant A, 520mL:(Na 140.0, K 4.00, Cl 125.0 mmol/L)Calibrant B, 190mL:(Na 70.0, K 8.00, Cl 41.0 mmol/L)REF 5421 Cleaning Solution	ISE Buffer, PN: AUH1011ISE Reference, PN: AUH1013ISE Mid Standard,(PN:AUH1012)Internal Reference Solution,(PN: AUH1017)ISE Low Standard, PN: 1014ISE High Standard, PN: 1015Na Selectivity Check, PN: AUH1018

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ELECTRODES

XL-200 Clinical Chemistry Analyzer

*REF 5201: Na Electrode *REF 5202: K Electrode *REF 5207: Cl Electrode *REF 5204: Reference Electrode Beckman Coulter Olympus 400 Electrodes

MU9194: Na Electrode MU9195: K Electrode MU9196: Cl Electrode

JAS Expected values/Reference ranges:

Sodium: 136 to 145mmol/L Potassium: 3.5 to 5.1mmol/L Chloride: 98 to 107 mmol/L Olympus Expected values/ Reference ranges: 136 to 145mEq/L 3.5 to 5.1mEq/L 98 to 107 mEq/L

15.) Performance Characteristics - ISE

Linearity (serum)

Protocol: Serial Dilutions of a Stock Standard were prepared for Sodium, Potassium and Chloride and run on the XL-200 Clinical Chemistry Analyzer. Results were then plotted as a regression graph against theoretical recovery.

Results: Slopes and Intercepts resulted for Sodium, Potassium and Chloride, linear within allowable nonlinearity of 3mg/dL or 5%; validating the products' below claimed linearity ranges.

mEq/L

Sodium	100 to 200 mEq/L
Potassium	1.0 to 10.0 mEq/L
Chloride	50 to 150 mEq/L

Calibrator Traceability:

Protocol: Verichem Laboratories Matrix Plus Chemistry Reference Kit (9500) five level reference material was run on the XL-200 Clinical Chemistry Analyzer, for XL-200 Sodium, Potassium, and Chloride. This material is "Verified and lot certified using available standard reference materials for the National Institute of Standards and Technology (NIST); for Calibration Verification"

Results:

Program's Evaluation of Results states Sodium, Potassium, and Chloride accuracy tests passed and results linear; with the following statistics:

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Test	Slope	Intercept	Error
Sodium	1.007	4.4mmol/L	0.1%
Potassium	0.902	0.1mmol/L	1.3%
Chloride	1.012	2.0mmol/L	1.3%

Precision:

Protocol: Precision was performed using "EP Evaluator's NCCLS EP5-T2 Precision document (NCCLS.EP5)" program. Three sodium, potassium and chloride sample levels were run 20 times in duplicate, using 20 runs over a 20 day period on the XL-200 Clinical Chemistry Analyzer, for within run and for total imprecision calculation/determination.

Results: Results were entered into Rhoads EP Evaluator Software for determining precision S.D. and CV levels. All results below meet requirement of CV (%) < 5% for both within and total precision.

Sodium
Within Run:	Level 1	Level 2	Level 3
Mean (mmol/L)	118.2	131.5	166.6
S.D. (mmol/L)	0.340	0.40	0.82
C.V. (%)	0.3	0.3	0.5
Total:
S.D. (mmol/L)	0.808	1.08	1.36
C.V. (%)	0.7	0.8	0.8
Potassium
Within Run:	Level 1	Level 2	Level 3
Mean (mmol/L)	1.84	3.43	6.13
S.D. (mmol/L)	0.035	0.011	0.038
C.V. (%)	1.9	0.3	0.6
Total:
S.D. (mmol/L)	0.038	0.026	0.066
C.V. (%)	2.1	0.8	1.1
Chloride
Within Run:	Level 1	Level 2	Level 3
Mean (mmol/L)	88.3	108.5	120.0
S.D. (mmol/L)	0.45	0.68	0.301
C.V. (%)	0.5	0.6	0.3
Total:
S.D. (mmol/L)	0.73	0.80	0.559

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C.V. (%)	0.8	0.7	0.5
----------	-----	-----	-----

Interferences

Protocol: Serial dilutions were prepared using a high interferent sample material, with the same sample material (sodium, potassium and chloride level respectively) without the interferent spiked. Acceptable interference level is the is the highest interferent sample level were the glucose values remains within 10% of the sample value unspiked with the intereferent.

Results: The following highest interferent levels for the sample, with < 10% interferent were obtained.

Reagent	Hemolysis	Lipemia	Bilirubin
Sodium	Hemolyzed samples should not be used	1084 mg/dL	22.5 mg/dL
Potassium	Hemolyzed samples should not be used	1084 mg/dL	22.5 mg/dL
Chloride	Hemolyzed samples should not be used	1084 mg/dL	22.5 mg/dL

Method Comparison Studies: (versus Olympus reagent on Olympus 400 analyzer)

Protocol: Multiple serum samples, at various analyte levels, were run on multiple days through the test's analytical range on the XL-200 clinical chemistry analyzer using JAS reagent packs (y method) and also on the Beckman Coulter Olympus 400, using Olympus ISE solution as a reference instrument (y method). Results were compared using a correlation plot.

Results: The following acceptable statistics resulted, i.e. R > 0.95, Slope between 0.90 and 1.10, and intercept close to 0 mg/dL level

Sodium

Number of sample pairs:	101
Range tested: x method	103 to 193 mmol/L
Range tested: y method	101 to 190 mmol/L
Correlation Coefficient	0.9917
Slope:	0.984
Intercept:	2.256 mmol/L

Potassium

Number of sample pairs:	90
Range tested: x method	1.2 to 9.90 mmol/L
Range tested: y method	1.1 to 10.0 mmol/L
Correlation Coefficient	0.9954
Slope:	0.999
Intercept:	0.05 mmol/L

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Chloride

88 Number of sample pairs: 51 to 140 mmol/L Range tested: x method Range tested: y method 51 to 145 mmol/L Correlation Coefficient 0.9856 Slope: 1.070 - 4.3 mmol/L Intercept:

The submitted information in this pre-market notification is complete and supports a substantial equivalence decision.

I .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/14/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MI) 20993-00002

May 15, 2014

JAS DIAGNOSTICS. INC. DAVID JOHNSTON VP. RESEARCH AND DEVELOPMENT 14100 N.W. 57TH COURT MIAMI LAKES FL 33014

Re: K130915 Trade/Device Name: JAS Glucose Reagent ISE Reagent Pack XL-200 Clinical Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR, JGS. CEM. CGZ. JJE Dated: April 30, 2014 Received: May 2. 2014

Dear Mr. David Johnston:

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 docs 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 (OS) regulation (21 CFR Part 820); and if applicable, the

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Page 2-Mr. David Johnston

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-five number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.lda.gov/MedicalDevices/Safety/ReportalProblem/defiult.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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K130915

Device Name

XL-200 Clinical Chemistry Analyzer, JAS Glucose Reagent, ISE Reagent Pack

Indications for Use (Describe)

Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY :

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Regulation Number and Section

§ 862.2160 Discrete photometric chemistry analyzer for clinical use.

(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.