PICCOLO METLYTE 7 REAGENT DISC

K992140 · Abaxis, Inc. · JLB · Aug 26, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992140
• Device Name: PICCOLO METLYTE 7 REAGENT DISC
• Applicant: Abaxis, Inc.
• Product Code: JLB · Clinical Chemistry
• Decision Date: Aug 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1210
• Device Class: Class 1

Intended Use

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.

Device Story

Piccolo MetLyte 7 Reagent Disc is a single-use consumable for the Piccolo Point-of-Care Chemistry Analyzer. It processes heparinized whole blood, plasma, or serum samples. The disc performs centrifugal separation of blood cells from plasma, meters precise volumes of plasma and diluent, and mixes them with dry reagent beads located on the disc. Chemical reactions occur within the disc's reaction cuvettes; these are monitored by the analyzer's optical system. The analyzer provides quantitative results for creatine kinase, creatinine, glucose, potassium, total carbon dioxide, and urea nitrogen. Used in clinical laboratories or point-of-care settings by healthcare professionals. Results assist clinicians in diagnosing and monitoring conditions like myocardial infarction, renal disease, and metabolic disorders. The system benefits patients by providing rapid, on-site diagnostic information.

Clinical Evidence

Bench testing only. Linearity, precision, and method comparison studies were performed. Precision studies (n=120) showed CVs ranging from 1.5% to 10.7% across analytes. Method comparison studies (n=47-60) demonstrated correlation coefficients between 0.947 and 0.969 compared to predicate systems. Linearity was confirmed at the 99% significance level.

Technological Characteristics

Consumable reagent disc containing dry, test-specific reagent beads. Uses centrifugal force for sample separation and metering. Analyzes samples at 37°C. Calibration via bar-coded disc-specific data. Connectivity via analyzer interface. Software-controlled automated processing.

Indications for Use

Indicated for quantitative determination of creatine kinase, creatinine, glucose, potassium, total carbon dioxide, and urea nitrogen in human heparinized whole blood, plasma, or serum. Used in diagnosis/treatment of myocardial infarction, muscular dystrophy, renal disease, diabetes, metabolic disorders, and acid-base imbalances. No specific age or gender restrictions noted.

Regulatory Classification

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.

Predicate Devices

• KNA™ 2 Sodium-Potassium Analyzer (K830805)
• Roche Reagents for carbon dioxide and creatine kinase on the COBAS FARA™ Chemistry System (CK: K834502, CO2: K844987)

Submission Summary (Full Text)

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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:

2.

| Date Prepared:<br>Name:<br>Address: | June 22, 1999<br>Abaxis, Inc.<br>1320 Chesapeake Drive<br>Sunnyvale, CA 94089 | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Contact Person:<br>Phone Number:<br>Fax Number: | Lisa G. McGrath<br>[phone]<br>[phone] | |
| Device Information: | | |
| Classification<br>Trade Name: | Class II<br>Creatine Kinase, Potassium and Total Carbon Dioxide<br>test systems included on the Piccolo MetLyte 7 Reagent Disc | |
| Classification Name: | Bicarbonate/Bicarbonate test system<br>Creatinine Kinase test system | 862.1160<br>862.1215 |

(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 | | | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------|-----------------------------|
| | Predicate<br>Device | Manufacturer | 510(k) Number | Date of SE<br>Determination |
| Piccolo®<br>Potassium Test<br>System | KNA™ 2<br>Sodium-<br>Potassium<br>Analyzer | Radiometer<br>America, Inc. | K830805 | 4/8/83 |
| Piccolo Creatine<br>Kinase and Total<br>Carbon Dioxide<br>Test System | Roche<br>Reagents<br>for carbon<br>dioxide and<br>creatine<br>kinase on<br>the COBAS<br>FARA™<br>Chemistry<br>System | Roche<br>Diagnostic<br>Systems, Inc. | CK: K834502<br>CO2 K844987 | 2/27/84<br>1/18/85 |

#### 4. Description of the Device:

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.

#### 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-Care<br>Chemistry Analyzer | COBAS FARATM Chemistry<br>System |
| Intended Use | quantitative analysis of<br>creatine kinase | quantitative determination of<br>creatine kinase |
| Methodology | isoenzymes | isoenzymes |
| Sample Type | whole blood, plasma,<br>serum | serum |
| Sensitivity | 0.0001 A/min/U/L | 0.0001 A/min/U/L |
| Reagents | dry test-specific reagent<br>beads | liquid mono reagent |
| Temperature | 37°C | 37°C |
| Calibration | bar code with disc-<br>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-Care<br>Chemistry Analyzer | Radiometer KNA™ 2<br>Sodium-Potassium Analyzer |
| Intended Use | quantitative analysis of<br>potassium | quantitative determination of<br>potassium |
| Methodology | enzymatic activation | ion-selective electrodes |
| Sample Type | whole blood, plasma,<br>serum | whole blood, plasma, serum,<br>urine |
| Sensitivity | 0.024 A/min/mmol/L | 0.58 (mmol/L)/(mV) |
| Reagents | dry, test specific reagent<br>beads | N/A |
| Temperature | 37° C | 37° C |
| Calibration | bar code with disc-<br>specific calibration data | automatic 1 point calibration<br>every 2 hours; 2 point<br>calibration 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-Care<br>Chemistry Analyzer | COBAS FARA™ Chemistry<br>System |
|-----------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended Use | quantitative analysis of<br>total carbon dioxide | quantitative determination of<br>total carbon dioxide |
| Methodology | enzymatic | enzymatic using phos-<br>phoenol pyruvate carbo-<br>xylase and malate de-<br>hydrogenase |
| Sample Type | whole<br>blood, plasma, serum | serum and plasma |
| Sensitivity | 0.0037 A/min/mmol/L | 0.0427 A/mmol/L |
| Reagents | dry test-specific reagent<br>beads | liquid substrate reagent 1 and<br>liquid enzyme reagent 2 |
| Temperature | 37° C | 37° C |
| Calibration | bar code with disc-<br>specific calibration data | Roche calibrator serum<br>every 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<br>(n = 120) | Total<br>(n= 120) |
|-------------------------------|-------------------------|-------------------|
| Creatine Kinase (U/L) | | |
| Moni-Trol 1<br>Mean | 134 | 134 |
| SD | 2.7 | 2.7 |
| CV | 2.0 | 2.0 |
| Moni-Trol 2<br>Mean | 526 | 526 |
| SD | 7.7 | 7.7 |
| CV | 1.5 | 1.5 |
| Potassium (mmol/L) | | |
| Moni-Trol 1<br>Mean | 6.1 | 6.1 |
| SD | 0.32 | 0.35 |
| CV | 5.2 | 5.7 |
| Moni-Trol 2<br>Mean | 4.1 | 4.1 |
| SD | 0.24 | 0.26 |
| CV | 5.9 | 6.3 |
| Total Carbon Dioxide (mmol/L) | | |
| Moni-Trol 1<br>Mean | 21 | 21 |
| SD | 2.29 | 2.29 |
| CV | 10.7 | 10.7 |
| Moni-Trol 2<br>Mean | 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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.

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.

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.

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.

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.

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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)

OR

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

Jev Harcey