APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201

K080125 · Wako Chemicals USA, Inc. · LBS · Jul 18, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080125
• Device Name: APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
• Applicant: Wako Chemicals USA, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole The APOLOWAKO TG is for the quantitative determination on the blood. APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio. APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.

Device Story

APOLOWAKO system performs automated lipid panel analysis on venous whole blood; includes APOLOWAKO Analyzer and reagent kits. System uses centrifugal separation to isolate plasma within single-use measurement disks; performs colorimetric, enzyme-based assays for total cholesterol, HDL-C, and triglycerides. LDL-C calculated via Friedewald equation for triglycerides ≤400 mg/dL. Analyzer features automated liquid dispensing, temperature-controlled reagent carousel, and display. Reagents utilize information tags for calibration and lot management. Used in point-of-care sites and central labs by clinicians/technicians. Provides quantitative results to assist in CHD/CVD risk assessment. Includes 'Serum Index' feature to detect hemolysis, icterus, and lipemia via spectrophotometric absorbance at 340, 405, and 450 nm; automatically halts analysis if interferants exceed thresholds.

Clinical Evidence

Clinical method comparison study conducted on 388 samples (384 for HDL-C). Results showed statistically significant correlation with reference methods; slopes approached 1.0, y-intercepts approached zero, and correlation coefficients were ≥ 0.945 for all assays. Data met requirements for CLIA Waiver.

Technological Characteristics

Discrete photometric chemistry analyzer; liquid reagent-based colorimetric, enzyme-based assay. Dimensions: 31cm x 47.5cm x 56cm; weight: 25kg. Features automated liquid dispensing, temperature-controlled reagent carousel, and reagent information tags for parameter control. Calibration required every 28 days. Connectivity/software details not specified beyond automated monitoring of measurement processes.

Indications for Use

Indicated for the measurement of total cholesterol, HDL cholesterol, triglycerides, and calculated LDL cholesterol (for triglyceride values up to 400 mg/dL) in whole blood. Used in conjunction with other biochemical markers and coronary risk factors to predict CHD/CVD risk and assess CHD/CVD severity.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• CHOLESTECH LDX (k954778)
• Beckman Unicel DxC 800 (k042291)

Submission Summary (Full Text)

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#### Wako Wako Diagnostics

JUL 1 8 2008

# SECTION 9

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K080125.

Wako Diagnostics 807.92 (a)(1): Name:

> Address: 665 Clyde Avenue, Suite B Mountain Vicw, CA 94043 Phone: [phone] FAX: [phone] Contact: Peter Panfili, Ph.D.

## 807.92 (a)(2): Device name- trade name and common name, and classification

### Trade Name:

APOLOWAKO Lipid Panel*, composed of; APOLOWAKO T-CHO APOLOWAKO HDL-C APOLOWAKO TG APOLOWAKO Analyzer and accessories

* APOLOWAKO Lipid Panel is a generic name for the above three reagents for lipids determination in whole

## Common Name:

Test system for individual reporting of:

- total cholesterol
- HDL cholesterol -
- triglyccrides -
- LDL cholesterol (by Friedewald calculation) -
- -Discrete photometric chemistry analyzer for clinical use

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Image /page/1/Picture/0 description: The image shows the logo for Wako Diagnostics. The word "Wako" appears twice, once in a black box on the left and again in black text on a white background to the right. The word "Diagnostics" appears to the right of the second "Wako".

## Classification:

Total cholesterol: §21.862.1175 HDL cholesterol: §21.862.1475 Triglycerides: \$21.862.1705 LDL cholesterol: §21.862.1475 (by calculation) Discrete photometric chemistry analyzer for clinical use: 821.862.2160

# 807.92 (a)(3): Identification of the legally marketed predicate device

CHOLESTECH LDX, Cholestech Corporation, Hayward, CA cleared under K954778 and K946067 for lipids.

### 807.92 (a)(4): Device Description

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

# 807.92 (a)(5): Intended Use

The APOLOWAKO Lipid Panel is for the quantitative determination of total cholesterol. HDL cholesterol and triglycerides in whole blood and also calculates and gives results for LDL cholesterol and the T-CHO/HDL-C ratio.

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# 807.92 (a)(6): Technological Similarities and Differences to the Predicate

| Predicate Device (Cholestech LDX) | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CHARACTERISTIC | APOLOWAKO Analyzer | Cholestech LDX System |
| Intended Use | The APOLOWAKO Lipid<br>Panel is used for the in vitro<br>quantitative determination of<br>total cholesterol, HDL<br>cholesterol, LDL cholesterol<br>(by calculation), triglycerides<br>in whole blood and the T-<br>CHO/HDL-C ratio. | The Cholestech LDX System<br>is used for the quantitative<br>determination of total<br>cholesterol, HDL (high-<br>density lipoprotein)<br>cholesterol and triglycerides<br>glucose in whole blood. A<br>TC/HDL (total<br>cholesterol/HDL cholesterol<br>ratio and estimated values for<br>LDL (low density<br>lipoprotein) and non-HDL<br>cholesterol are calculated by<br>the Cholestech LDX. |
| Indications for Use | The measurement of total<br>cholesterol, HDL cholesterol,<br>LDL cholesterol, and<br>triglycerides when used in<br>conjunction with other<br>biochemical markers and<br>coronary risk factors, is<br>useful in the prediction of<br>CHD/CVD risk and the<br>assessment of CHD/CVD<br>severity. | Lipoprotein measurements<br>are used in the diagnosis and<br>treatment of lipid disorders<br>such as diabetes mellitus,<br>atherosclerosis, and various<br>liver and renal diseases. |
| Sample | Whole blood | Whole blood |
| Sample Preparation | Venous whole blood sample | Finger stick or venous whole<br>blood sample |
| Calibration | Calibration is required at the<br>time the reagent is opened<br>and lasts for 28 days or until<br>expiration date. | No calibration is performed<br>by the user. |
| Methodology | Colorimetric, enzyme-based | Colorimetric |
| Reagent Format | Liquid | Dry |
| Testing Environment | Professional use, point-of-<br>care | Professional use, point-of-<br>care |
| | | |
| Reportable<br>range | T-CHO: 25-330 mg/dL<br>HDL-C: 8.0-100 mg/dL<br>TG: 30-625 mg/dL<br>LDL-C by calculation | T-CHO: 100 to 500 mg/dL<br>HDL-C: 15-100 mg/dL<br>TG: 45-650 mg/dL<br>LDL-C by calculation |
| Precision | T-CHO: Total imprecision less than 2.0% CV across a range of 133 mg/dL to 788 mg/dL (mean values)<br>HDL-C: Total imprecision less than 2.0% CV across a range of 38.8 mg/dL to 100.3 mg/dL (mean values)<br>TG: Total imprecision less than 2.0% across a range of 90 mg/dL to 1178 mg/dL (mean values) | T-CHO: Total imprecision less than 4.0% across a range of 161 mg/dL to 244 mg/dL (mean values)<br>HDL-C: Total imprecision less than 6.5% CV across a range of 29 mg/dL to 46 mg/dL (mean values)<br>TG: Total imprecision less than 3.2% across a range of 121 mg/dL to 276 mg/dL (mean values) |
| Linearity | Assay linear throughout reportable range | Assay linear throughout reportable range |
| Interfering<br>Substances | No interference from high levels of bilirubin (conjugated and unconjugated), hemoglobin, EDTA-2Na, heparin sodium and ascorbic acid.<br>No interference from triglycerides on T-CHO and HDL-C measurements. | There are 23 substances including hemoglobin, bilirubin and uric acid that did not interfere with the assay. Free glycerol does affect Cholestech TG test but it does not affect APOLOWAKO TG. |

# Similarities / Differences between the APOLOWAKO Lipid Panel and Established Predicate Device (Cholestech LDX)

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### 807.92 (b)(1): Brief Description of Non-clinical Data

Evaluations were performed for within-day imprecision, between-day imprecision, linearity, and interfering substances. Those resulting data are summarized below.

Triglyceride

Within-day imprecision, when evaluated at three levels of triglyceride (low- 45 mg/dL, intermediate- 139 mg/dL, and high- 1209 mg/dL), ranged from 0.5 % CV to 2.9 % CV. Between-day imprecision, when evaluated in duplicate over 10 days, ranged 0.9 % CV to 1.8 % CV.

Results from linearity studies demonstrated that the triglyceride is linear throughout the reportable range.

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#### Wako Diagnostics Wako

Results from an interference testing showed triglyceride assay is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated) or free glycerol.

## Total Cholestcrol

Within-day imprecision, when evaluated at three levels of total cholesterol (low- 122 mg/dL, intermediate- 187 mg/dL, and high- 764 mg/dL), ranged from 0.5 % CV to 1.2 % CV. Between-day imprecision, when evaluated in duplicate over 10 days, ranged 0.6 % CV to 1.7 % CV.

Results from linearity studies demonstrated that the total cholesterol is linear throughout the reportable range.

Results from an interference testing showed that the total cholesterol is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, or heparin sodium.

# HDL-C

Within-day imprecision, when cvaluated at three levels of HDL-C (low-30.8 mg/dL, intermediate- 51.1 mg/dL, and high- 95.2 mg/dL), ranged from 0.5 % CV to 1.6 % CV. Between assay imprecision, when evaluated in duplicate over 10 days, ranged 0.5 % CV to 1.6 % CV.

Results from linearity studies demonstrated that the HDL-C assay is linear throughout the reportable range.

Results from an interference testing showed that the HDL-C is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, or heparin sodium.

# 807.92 (b)(2): Brief Description of Clinical Data

The method comparison study shows substantial equivalence to FDA cleared comparison methods for total cholesterol, triglycerides and HDLcholesterol. For each analyte. 388 (384 for HDL-cholesterol; 4 samples out of the detectable range) broadly distributed samples showed statistically significant correlation with the reference method with slopes approaching 1.0 and y-intercepts approaching zero. APOLOWAKO results were collected under rigorous conditions sufficient to meet the requirements for CLIA Waiver. The results show correlation coefficients of 0.945 or better for each assay.

# 807.92 (b)(3): Conclusions from Non-clinical and Clinical Testing

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUL 1 8 2008

Wako Chemicals USA, Inc. c/o Peter Panfili, Ph.D. 665 Clyde Avenue, Suite B Mountain View, CA 94043

k080125 Re:

> Trade/Device Name: APOLOWAKO T-CHO, APOLOWAKO HDL-C, APOLOWAKO TG and APOLOWAKO Analyzer and accessories Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: CGO, CDT, LBS and JJE Dated: June 24, 2008 Received: June 30, 2008

Dear Dr. Panfili:

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.

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 can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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# Indication for Use

## 510(k) Number (if known): k080125

### Device Name:

APOLOWAKO T-CHO APOLOWAKO HDL-C APOLOWAKO TG APOLOWAKO Analyzer and accessories

# Intended Use

The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole The APOLOWAKO TG is for the quantitative determination on the blood. APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.

APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.

# Indications for Use

The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.

| Prescription Use<br>(21 CFR Part 801 Subpart D) | X | And/Or | Over the Counter Use<br>(21 CFR Part 801 Subpart C) |
|-------------------------------------------------|---|--------|-----------------------------------------------------|
|-------------------------------------------------|---|--------|-----------------------------------------------------|

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

Concurrence of CDRH Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

*Carol Benson*

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) K080125