PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM

K051108 · Abaxis, Inc. · CFJ · Jul 8, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051108
• Device Name: PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: CFJ · Clinical Chemistry
• Decision Date: Jul 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1440
• Device Class: Class 2

Intended Use

The Piccolo Lactate Dehydrogenase Test System (presently contained on the Chemotherapy Evaluation Panel Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis and cirrhosis; cardiac diseases such as myocardial infarction; and tissue alterations of the heart, kidney, liver, and muscle.

Device Story

Piccolo Lactate Dehydrogenase Test System utilizes reagent discs containing dry reagent beads and liquid diluent; analyzer meters sample (heparinized plasma/serum) and diluent; mixes reagents; performs enzymatic rate reaction at 37°C. Analyzer monitors chemical reactions via optical detection. System provides quantitative LDH activity results (50-1,000 U/L). Used in clinical labs or point-of-care settings by healthcare professionals. Output assists clinicians in diagnosing/treating liver, cardiac, and muscle tissue conditions. Factory-calibrated via barcode on disc.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing, including precision (n=80, total CV 2.0-5.0%), linearity (R2=0.998), and method comparison against the predicate (n=60, slope 0.989, correlation 0.994). Interference testing was conducted for endogenous substances and drugs. Reference intervals were established via regression analysis against the predicate.

Technological Characteristics

Single-use 8 cm reagent disc containing lyophilized microspheres (Lactate, NAD+, Diaphorase, INT). Enzymatic reaction monitored bichromatically at 500 nm and 630 nm at 37°C. Standalone point-of-care analyzer platform. Calibration via bar-coded lot-specific data. Complies with NCCLS standards EP9-A2, EP5-A2, EP18-A, EP6-A, EP7-A, and C28-A2.

Indications for Use

Indicated for in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum for patients requiring diagnosis or treatment monitoring of liver disease, cardiac disease, or tissue alterations of heart, kidney, liver, or muscle. For prescription use only.

Regulatory Classification

Identification

A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Predicate Devices

• Lactate Dehydrogenase Synchron LX20 (k011213)

Submission Summary (Full Text)

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JUL - 8 2005

3240 Whipple Road, Union City, CA 94587 510 · 675-6500 Fax 510 · 441-6150 Phone

Image /page/0/Picture/4 description: The image shows the logo for ABAXIS. The logo is in black and white and features the company name in bold, sans-serif font. A stylized oval shape encircles the letters 'XIS' of the company name, adding a visual element to the 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: | April 29, 2005 |
|-----------------|-------------------------------------------|
| Name: | Abaxis, Inc. |
| Address: | 3240 Whipple Road<br>Union City, CA 94587 |
| Contact Person: | Dennis M. Bleile, PhD |
| Phone Number: | [phone] |
| Fax Number: | [phone] |

#### Device Information: 2.

| Classification | Class II |
|----------------|--------------------------------------------|
| Trade Name: | Piccolo® Lactate Dehydrogenase Test System |

Classification Name: Lactate Dehydrogenase Test system 862.1440

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

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

| Predicate Device | | | |
|-------------------------------------------------------------------------------|-------------------------------------|------------------|-----------------------------|
| Predicate Device | Manufacturer | 510(k)<br>Number | Date of SE<br>Determination |
| Lactate Dehydrogenase<br>Reagents on the<br>Synchron LX20<br>Chemistry System | Beckman Coulter,<br>Inc. (Brea, CA) | K011213 | 5/16/01 |

### Description of the Device: 4.

The Piccolo Basic Metabolic Panel Plus Reagent Disc (which contains the Piccolo The Thoolo Dacto MetaTest System) is designed for heparinized plasma and serum, only. The disc meters the required quantity of sample and diluent, mixes

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## Summary of Safety and Effectiveness (continued)

the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted samples 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 Lactate Dehydrogenase Test System (presently contained on the Basic Metabolic Panel Plus Reagent Disc) used with the Piccolo Point-of-Care Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate dehydrogenase activity in heparinized plasma or serum in a clinical laboratory setting or point-of-care location.

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

outlines the technological characteristics of the Piccolo Lactate ← Table Dehydrogenase Test System in comparison to the legally marketed predicate device.

| | Piccolo Point-of-Care<br>Chemistry Analyzer | Synchron LX20 Chemistry<br>System |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative analysis of<br>Lactate Dehydrogenase | Quantitative analysis of<br>Lactate Dehydrogenase |
| Methodology | Enzymatic rate reaction | Enzymatic rate reaction |
| Sample Type | Heparinized plasma and serum | Heparinized plasma and serum |
| Sensitivity | 50 U/L | 5 U/L |
| Reagents | Dry test-specific reagent beads<br>and liquid diluent; reconstitution<br>performed by analyzer<br><br>Active ingredients:<br>Lactate<br>Nicotinamide adenine<br>dicucleotide (NAD+)<br>Diaphorase<br>p-Iodonitrotetrazolium Violet<br>(INT) | Liquid reagents<br><br>Active ingredients:<br>Lactate<br>Nicotinamide adenine<br>dicucleotide (NAD+) |
| Temperature of<br>Reaction | 37°C | 37°C |
| Calibration | Bar code with factory<br>calibrated lot specific data | Calibration not required. |
| Assay Range | 50 - 1,000 U/L | 5 - 750 U/L<br>(600 - 2,700 U/L ORDAC*) |
| Testing Environment | Professional use | Professional use |

# Table 1: Specification Comparison: Piccolo Lactate Dehydrogenase Test System

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# Summary of Safety and Effectiveness (continued)

Table 1: Specification Comparison: Piccolo Lactate Dehydrogenase Test System (continued)

| | Piccolo Point-of-Care<br>Chemistry Analyzer | Synchron LX20 Chemistry<br>System |
|-------------|---------------------------------------------|-----------------------------------|
| Sample Size | Approximately 100 µL | 13 µL<br>(3 µL ORDAC*) |

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

Tables 2 summarize the results of clinical and non-clinical tests performed using the Piccolo Lactate Dehydrogenase Test System.

Linearity:

## Table 2: Summary of Linearity

| | Lactate<br>Dehydrogenase | |
|-------------------|--------------------------|--|
| Slope | 1.012 | |
| Intercept | +0.253 | |
| Corr. Coefficient | 0.998 | |

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## Summary of Safety and Effectiveness (continued)

### Precision:

Precision studies were designed to evaluate within-run and total precision of the Lactate Dehydrogenase Test System when run on the Piccolo Point-of-Care Chemistry Analyzer.

## Table 3: Within-Run and Total Precision for Lactate Dehydrogenase, Assayed on the Piccolo Point-of-Care Chemistry Analyzer

| Analyte | Within-Run<br>(n = 80) | Total<br>(n = 80) |
|-----------------------------|------------------------|-------------------|
| Lactate Dehydrogenase (U/L) | | |
| Control Level 1 | | |
| Mean | 87 | 87 |
| SD | 3.0 | 4.4 |
| %CV | 3.4 | 5.0 |
| Control Level 2 | | |
| Mean | 350 | 350 |
| SD | 3.8 | 7.0 |
| %CV | 1.1 | 2.0 |

### Sample Type Comparison:

A study was conducted to examine and compare results for heparinized plasma and serum on the Piccolo® Point-of-Care Chemistry Analyzer.

Heparinized plasma and serum comparability were established for Lactate Dehydrogenase.

#### Conclusions 8.

The clinical and non-clinical tests performed for Lactate Dehydrogenase, when run on the Piccolo Point-of-Care Chemistry Analyzer, demonstrate that the test system is as safe, effective and performs as well as the legally marketed device identified above.

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.

:

Abaxis Confidential

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top half of the circle.

Public Health Service

JUL - 8 2005

Food and Drug Administrat 2098 Gaither Road Rockville MD 20850

Dennis M. Bleile Ph.D. Director of Assay Performance &Compliance Abaxis, Inc 3240 Whipple Road Union City, CA 94587

Re: k051108

K031100
Trade/Device Name: Piccolo® Lactate Dehydrogenase Test Regulation Number: 21 CFR 862.1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: Class II Product Code: CFJ Dated: April 29, 2005 Received: May 2, 2005

Dear Dr. Bleile:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the stated in the encrosure) to regard nent date of the Medical Device Amendments, or to commerce prof to May 20, 1977, the enacements with the provisions of the Federal Food, Drug, devices mail have been recuire approval of a premarket approval application (PMA). alle Cosmetic Act (71cc) market the device, subject to the general controls provisions of the Act. The 1 ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of aactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may be subject to Sach additions (CFR), Parts 800 to 895. In addition, FDA can oc nound in This 21, Courtents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dr i loseants of the complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any reactal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Free Stocker Parts 801 and 809); and good manufacturing practice CI K Part 807), tabeling systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your section 5 10(k) I his letter will anow you to begin manketing your antial equivalence of your device to a legally premarked notification. The PDT Intuing of basicance of the super and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific intornation advartising of your device, please contact the Office of In
or questions on the promotion and advertising of your device, please contact th of questions on the promotion and Safety at [phone]. Also, please note the VIIro Diagnostic Device Development and Sales ... (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misolanding of responsibilities under the Act from the You may other other general informations on your Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K051108 |
|---------------------------|---------|
|---------------------------|---------|

Piccolo® Lactate Dehydrogenase Test System Device Name: _

Indications For Use:

The Piccolo Lactate Dehydrogenase Test System (presently contained on the The Piccolo Lactate Denyarogenato Treat Systems with the Piccolo Point-of-Care Precolo Basic Metabolic Panel Place Lused for the in vitro quantitative Chemilstly Analyzer 15 Interneta determination or oratory setting or point-of-care location.

Lactate dehydrogenase measurements are used in the diagnosis and treatment Lactate denydrogenase measurements and circhosis; cardiac diseases
of liver diseases such as acute viral hepatitis and cirches hart kidney, liver of liver diseases such as acute virus nopality and tissue alterations of the heart, kidney, liver, and muscle.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K051108