The Piccolo MetLyte 7 Reagent Disc, used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

Indications for Use:
Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism, surgery, severe exercise, intramuscular injection, physical inactivity, decreased muscle mass.

Creatinine The creatinine assay is used for the quantitation of creatinine in human heparinized whole blood, heparinized plasma, or serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis.

Glucose The glucose assay is used for the quantitation of glucose in human heparinized whole blood, heparinized plasma, or serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including adult and juvenile diabetes mellitus and hypoglycemia.

Potassium The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

Total Carbon Dioxide The total carbon dioxide assay is used for the quantitation of total carbon dioxide in human heparinized whole blood, heparinized plasma, or serum. Total carbon dioxide measurements are used in the diagnosis and treatment of primary MetLyte 7 alkalosis and primary respiratory alkalosis and acidosis.

Urea Nitrogen The urea nitrogen assay is used for the quantitation of urea nitrogen in human heparinized whole blood, heparinized plasma, or serum. Urea nitrogen measurements are used in the diagnosis and treatment of renal and MetLyte 7 diseases.

Device Description

The Piccolo MetLyte 7 Reagent Disc is designed to separate a heparinized 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. Alternately, the disc may also be used with serum.

AI/ML Overview

The provided text describes the acceptance criteria and study results for the Piccolo MetLyte 7 Reagent Disc for Creatine Kinase, Potassium, and Total Carbon Dioxide tests.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Performance Characteristics" sections in Tables 1-3, where the new device's performance (Piccolo® Point-of-Care Chemistry Analyzer) is compared to legally marketed predicate devices. The studies aim to show substantial equivalence.

Analyte	Performance Characteristic	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (Piccolo)
Creatine Kinase	Intended Use	quantitative determination of creatine kinase	quantitative analysis of creatine kinase
	Methodology	isoenzymes	isoenzymes
	Sample Type	serum	whole blood, plasma, serum
	Sensitivity	0.0001 A/min/U/L	0.0001 A/min/U/L
	Reagents	liquid mono reagent	dry test-specific reagent beads
	Temperature	37°C	37°C
	Calibration	pre-set calibration	bar code with disc-specific calibration data
	Assay Range	0 - 2,000 U/L	5 - 5,000 U/L
	Accuracy: Corr. Coeff.	(Not explicitly stated for predicate)	0.967
	Accuracy: Slope	(Not explicitly stated for predicate)	1.194
	Accuracy: Intercept	(Not explicitly stated for predicate)	-24.983
	Accuracy: SEE	(Not explicitly stated for predicate)	9.050
	Accuracy: R-Square	(Not explicitly stated for predicate)	0.934
Potassium	Intended Use	quantitative determination of potassium	quantitative analysis of potassium
	Methodology	ion-selective electrodes	enzymatic activation
	Sample Type	whole blood, plasma, serum, urine	whole blood, plasma, serum
	Sensitivity	0.58 (mmol/L)/(mV)	0.024 A/min/mmol/L
	Reagents	N/A (for KNA™ 2)	dry, test specific reagent beads
	Temperature	37° C	37° C
	Calibration	automatic 1 point calibration every 2 hrs; 2 point calibration every 8 hrs	bar code with disc-specific calibration data
	Assay Range	1.0 - 99.9 mmol/L	1.5 - 8.5 mmol/L
	Accuracy: Corr. Coeff.	(Not explicitly stated for predicate)	0.969
	Accuracy: Slope	(Not explicitly stated for predicate)	0.863
	Accuracy: Intercept	(Not explicitly stated for predicate)	0.573
	Accuracy: SEE	(Not explicitly stated for predicate)	0.141
	Accuracy: R-Square	(Not explicitly stated for predicate)	0.939
Total Carbon Dioxide	Intended Use	quantitative determination of total carbon dioxide	quantitative analysis of total carbon dioxide
	Methodology	enzymatic using phosphoenol pyruvate carbo-xylase and malate dehydrogenase	enzymatic
	Sample Type	serum and plasma	whole blood, plasma, serum
	Sensitivity	0.0427 A/mmol/L	0.0037 A/min/mmol/L
	Reagents	liquid substrate reagent 1 and liquid enzyme reagent 2	dry test-specific reagent beads
	Temperature	37° C	37° C
	Calibration	Roche calibrator serum every 6 months	bar code with disc-specific calibration data
	Assay Range	0 - 40 mmol/L	5 - 40 mmol/L
	Accuracy: Corr. Coeff.	(Not explicitly stated for predicate)	0.947
	Accuracy: Slope	(Not explicitly stated for predicate)	0.903
	Accuracy: Intercept	(Not explicitly stated for predicate)	2.444
	Accuracy: SEE	(Not explicitly stated for predicate)	0.837
	Accuracy: R-Square	(Not explicitly stated for predicate)	0.900
Linearity	Creatine Kinase	Statistically linear at 99% significance level	F-Ratio: 0.11, Slope: 1.00, Intercept: -7.45, Corr. Coeff.: 1.00
	Potassium	Statistically linear at 99% significance level	F-Ratio: 0.37, Slope: 1.05, Intercept: 0.03, Corr. Coeff.: 1.00
	Total Carbon Dioxide	Statistically linear at 99% significance level	F-Ratio: 0.88, Slope: 1.09, Intercept: -0.71, Corr. Coeff.: 0.97
Precision	Within-Run & Total CV Ratio	(Not explicitly stated, but expected to be low)	Creatine Kinase: CV 1.5-2.0%, Potassium: CV 5.2-6.3%, Total Carbon Dioxide: CV 8.6-10.7%

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

Creatine Kinase (Accuracy): n = 47 samples
Potassium (Accuracy): n = 58 samples
Total Carbon Dioxide (Accuracy): n = 60 samples
Linearity: The number of data points for the linearity analysis is not explicitly stated, only the F-ratio, slope, intercept, and correlation coefficient.
Precision: n = 120 (results pooled from 6 instruments each running 20 discs) for both within-run and total precision for each analyte.
Sample Type Comparison: A study was conducted, but the sample size is not specified.

Data Provenance: The document implies these are prospective studies conducted by Abaxis, Inc. No information on the country of origin of the data is provided, but the company is based in Sunnyvale, CA, USA. The data is for assessing the performance of the new device against predicate devices (retrospective comparison to predicate characteristics, but prospective data collection for the new device).

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

Not applicable. This study involves chemical analysis on a diagnostic device, not interpretation of images or patient data by human experts to establish ground truth. The "ground truth" for accuracy studies is typically the established reference method or the predicate device's results.

4. Adjudication Method for the Test Set

Not applicable, as this is a device performance study relying on quantitative measurements, not subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of a diagnostic device, not human reader performance with or without AI assistance.

6. Standalone Performance

Yes, the studies describe the standalone performance of the Piccolo MetLyte 7 Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer. The accuracy, linearity, and precision results presented are for the algorithm (device) only.

7. Type of Ground Truth Used

The ground truth for the accuracy studies appears to be the measurements obtained from the existing legally marketed predicate devices (COBAS FARATM Chemistry System for Creatine Kinase and Total Carbon Dioxide, and Radiometer KNA™ 2 Sodium-Potassium Analyzer for Potassium). For linearity and precision, the ground truth would be ideal linear performance and expected variability of control materials, respectively.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as it would for a machine learning algorithm. For an in vitro diagnostic device like this, the "development" or "calibration" data is implicitly used to establish the disc-specific calibration data that is embedded in a barcode. The accuracy, linearity, and precision studies represent independent validation or testing.

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

Not explicitly stated in terms of a "training set" ground truth. The device relies on "bar code with disc-specific calibration data." This implies the calibration data (which serves a similar role to a training set for the device's operational parameters) would have been established through a process of running known concentration standards. The details of this process and the ground truth used for it are not provided in this summary.

Summary

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AUG 26 1000

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS APPENDIX E

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1320 Chesapeake Terrace. Sunnyvale, Phone 408 . 734-0200 Fax 408 . 73

862.1600

Image /page/1/Picture/1 description: The image shows the word "ABAXIS" in bold, sans-serif font. A curved line starts from the top right of the letter "X", loops around the letters "I" and "S", and ends at the bottom right of the letter "S". The word and the curved line together form a logo.

This 510(k) summary of 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: __

1. Applicant Information:

Date Prepared:Name:Address:	June 22, 1999Abaxis, Inc.1320 Chesapeake DriveSunnyvale, CA 94089
Contact Person:Phone Number:Fax Number:	Lisa G. McGrath(408) 745-6880(408) 734-2874
Device Information:
ClassificationTrade Name:	Class IICreatine Kinase, Potassium and Total Carbon Dioxidetest systems included on the Piccolo MetLyte 7 Reagent Disc
Classification Name:	Bicarbonate/Bicarbonate test systemCreatinine Kinase test system	862.1160862.1215

(Substantial equivalence for creatinine kinase, glucose and urea nitrogen, which are test systems included on the Piccolo MetLyte 7 Reagent Disc, were established previously in K934592 and K942782, therefore these test systems are not included in this summary.)

Potassium test system

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ldentification of legally marketed device to which the submitter claims 3. equivalence:

The following table identifies the legally marketed device to which Abaxis claims equivalence:

Subject Device	Predicate Device
	PredicateDevice	Manufacturer	510(k) Number	Date of SEDetermination
Piccolo®Potassium TestSystem	KNA™ 2Sodium-PotassiumAnalyzer	RadiometerAmerica, Inc.	K830805	4/8/83
Piccolo CreatineKinase and TotalCarbon DioxideTest System	RocheReagentsfor carbondioxide andcreatinekinase onthe COBASFARA™ChemistrySystem	RocheDiagnosticSystems, Inc.	CK: K834502CO2 K844987	2/27/841/18/85

4. Description of the Device:

5. Statement of Intended Use:

The Piccolo MetLyte 7 Reagent Disc run on the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide and urea nitrogen in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.

6. Summary of the technological characteristics of the new device in comparison to those of the predicate device:

Tables 1 - 3 outline the technological characteristics of the Piccolo MetLyte 7 Reagent Disc (for creatine kinase, potassium and total carbon dioxide) in comparison to those of the legally marketed predicate devices.

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Table 1: Specification Comparison Creatine Kinase Test System
	Piccolo® Point-of-CareChemistry Analyzer	COBAS FARATM ChemistrySystem
Intended Use	quantitative analysis ofcreatine kinase	quantitative determination ofcreatine kinase
Methodology	isoenzymes	isoenzymes
Sample Type	whole blood, plasma,serum	serum
Sensitivity	0.0001 A/min/U/L	0.0001 A/min/U/L
Reagents	dry test-specific reagentbeads	liquid mono reagent
Temperature	37°C	37°C
Calibration	bar code with disc-specific calibration data	pre-set calibration
Assay Range	5 - 5,000 U/L	0 - 2,000 U/L
Performance Characteristics
Accuracy:
Sample size (n)	47
Range of Samples Tested	6.2 - 813.2
Corr. Coefficient	0.967
Slope	1.194
Intercept	-24.983
SEE	9.050
R-Square	0.934

Table 1: Specification Comparison Creatine Kinase Test System

Table 2: Specification Comparison: Potassium Test System

Table 2. Specification Comparison: Potassium Test System
	Piccolo Point-of-CareChemistry Analyzer	Radiometer KNA™ 2Sodium-Potassium Analyzer
Intended Use	quantitative analysis ofpotassium	quantitative determination ofpotassium
Methodology	enzymatic activation	ion-selective electrodes
Sample Type	whole blood, plasma,serum	whole blood, plasma, serum,urine
Sensitivity	0.024 A/min/mmol/L	0.58 (mmol/L)/(mV)
Reagents	dry, test specific reagentbeads	N/A
Temperature	37° C	37° C
Calibration	bar code with disc-specific calibration data	automatic 1 point calibrationevery 2 hours; 2 pointcalibration every 8 hours
Performance Characteristics
Assay Range	1.5 - 8.5 mmol/L	1.0 - 99.9 mmol/L
Accuracy:
Sample size (n)	58
Range of Samples Tested	2.0 - 6.8
Corr. Coefficient	0.969
Slope	0.863
Intercept	0.573
SEE	0.141
R-Square	0.939

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	Piccolo® Point-of-CareChemistry Analyzer	COBAS FARA™ ChemistrySystem
Intended Use	quantitative analysis oftotal carbon dioxide	quantitative determination oftotal carbon dioxide
Methodology	enzymatic	enzymatic using phos-phoenol pyruvate carbo-xylase and malate de-hydrogenase
Sample Type	wholeblood, plasma, serum	serum and plasma
Sensitivity	0.0037 A/min/mmol/L	0.0427 A/mmol/L
Reagents	dry test-specific reagentbeads	liquid substrate reagent 1 andliquid enzyme reagent 2
Temperature	37° C	37° C
Calibration	bar code with disc-specific calibration data	Roche calibrator serumevery 6 months
Performance Characteristics
Assay Range	5 - 40 mmol/L	0 - 40 mmol/L
Accuracy:
Sample size (n)	60
Range of Samples Tested	6.1 -38.5
Corr. Coefficient	0.947
Slope	0.903
Intercept	2.444
SEE	0.837
R-Square	0.900

Specification Comparison: Total Carbon Dioxide Test System Tahle 3-

7. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence.

Tables 4 - 5 summarize the results of clinical and non-clinical tests performed using the Piccolo MetLyte 7 Reagent Disc.

Linearity:

Data for creatine kinase, potassium and total carbon dioxide were found to be statistically linear at the 99% significance level by the F-test.

Table 4: Summary of Linearity

	Creatine Kinase	Potassium	Total Carbon Dioxide
F-Ratio	0.11	0.37	0.88
Slope	1.00	1.05	1.09
Intercept	-7.45	0.03	-0.71
Corr. Coefficient	1.00	1.00	0.97

(99% Critical F 2.99)

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Precision:

Precision studies were designed to evaluate within-run and total precision of the analytes included on the Piccolo® MetLyte 7 Reagent Disc when run on the Piccolo Point-of-Care Chemistry Analyzer.

Table 5: Within-Run and Total Precision for Creatine Kinase, Potassium and Total Carbon Dioxide Run on the Piccolo Point-of-Care Chemistry Analyzer ^

Analyte	Within-Run(n = 120)	Total(n= 120)
Creatine Kinase (U/L)
Moni-Trol 1Mean	134	134
SD	2.7	2.7
CV	2.0	2.0
Moni-Trol 2Mean	526	526
SD	7.7	7.7
CV	1.5	1.5
Potassium (mmol/L)
Moni-Trol 1Mean	6.1	6.1
SD	0.32	0.35
CV	5.2	5.7
Moni-Trol 2Mean	4.1	4.1
SD	0.24	0.26
CV	5.9	6.3
Total Carbon Dioxide (mmol/L)
Moni-Trol 1Mean	21	21
SD	2.29	2.29
CV	10.7	10.7
Moni-Trol 2Mean	10	10
SD	0.90	0.90
CV	8.6	8.6

A Results pooled from 6 instruments each running 20 discs.

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Sample Type Comparison:

A study was conducted to examine to compare venous whole blood. finger puncture whole blood and serum on the Piccolo® Point-of-Care Chemistry Analyzer.

Serum and whole blood comparability were established for each analyte and serum, whole blood and finger stick comparability were established for creatine kinase when run on the Piccolo Point-of-Care Chemistry Analyzer.

8. Conclusions

The clinical and non-clinical tests performed for creatine kinase, potassium and total carbon dioxide when run on the Piccolo Point-of-Care Chemistry Analyzer demonstrate that the test systems are as safe, effective and performs as well as the legally marketed devices identified above.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 26 1999

Ms. Lisa G. McGrath Regulatory Affairs Specialist Abaxis, Inc. 1320 Chesapeake Terrace Sunnyvale, California 94089

Re: K992140

Trade Name: Piccolo® MetLyte 7 Reagent Disc Regulatory Class: I reserved Product Code: JLB Dated: June 22, 1999 Received: June 24, 1999

Dear Ms. McGrath:

.. .

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K992140
---------------------------	---------

Device Name:

Piccolo® MetLyte 7 Reagent Disc

Intended Use:

Indications for Use:

Creatine Kinase The creatine kinase assay is used for the quantitation of creatine kinase in human heparinized whole blood, heparinized plasma, or serum. Measurements of creatine kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction, progressive muscular dystrophy, dermatomyositis, rhabdomyolysis due to drug ingestion, hyperosmolality, autoimmune disease, delirium tremens, convulsions, Crush syndrome, hypothyroidism, surgery, severe exercise, intramuscular injection, physical inactivity, decreased muscle mass.

The creatinine assay is used for the quantitation of creatinine in Creatinine human heparinized whole blood, heparinized plasma, or serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis.

The potassium assay is used for the quantitation of potassium in Potassium human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.

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Indications for Use, Page 2

The urea nitrogen assay is used for the quantitation of urea Urea Nitrogen nitrogen in human heparinized whole blood, heparinized plasma, or serum. Urea nitrogen measurements are used in the diagnosis and treatment of renal and MetLyte 7 diseases.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __
(Per 21 CFR 801.109)

Over- The Counter Use __
(Optional Format 1-2-96)

Jev Harcey

Regulation Number and Section

§ 862.1210 Creatine test system.

(a)
Identification. A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.(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 the limitations in § 862.9.