A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY

K080851 · Anticancer, Inc. · LPS · Oct 10, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080851
• Device Name: A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
• Applicant: Anticancer, Inc.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The AiC Enzymatic Homocysteine Assay is for in vitro diagnostic use.

Device Story

Device performs quantitative determination of total homocysteine (tHCY) in human plasma or serum; intended for small laboratory settings. Input: plasma or serum samples. Principle: three-step enzymatic reaction; reduction followed by depletion via Homocysteinase (rHCYase) to produce hydrogen sulfide (H2S); H2S reacts with N,N-dibutyl phenylene diamine (DBPDA) to form a chromophore. Output: fluorescence measured by A/C Diagnostics Reader (HyTek-205). Operation: manual assay process; 80-minute duration at room temperature; reader provides quantitative results. Healthcare providers use output to assist in diagnosis and treatment of hyperhomocysteinemia. Benefits: provides portable, enzymatic tHCY testing capability for smaller clinical environments compared to high-throughput automated analyzers.

Clinical Evidence

Method comparison study performed on 50 plasma samples comparing the A/C Portable Enzymatic Homocysteine Assay to the predicate Hitachi 912 system. Results showed a correlation coefficient of R=0.95, regression y=1.01+0.91, and a mean difference of 1.05 umol/L. Precision data: within-assay CV 3.8%–4.8%; between-assay CV 5.0%–7.4%.

Technological Characteristics

Enzymatic assay; reagents include dithiothreitol, homocysteinase, DBPDA, potassium ferricyanide. Instrumentation: A/C Diagnostics Reader (fluorescence). Sample vessels: 0.5 mL polypropylene PCR tubes. Connectivity: RS-232 serial port. Software: Moderate level of concern. Calibration: Daily curve generation required. Stability: 24h at 25°C, 2mo at 4°C, 2yr at -20°C.

Indications for Use

Indicated for the quantitative determination of total homocysteine (tHCY) in human plasma or serum to assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia.

Regulatory Classification

Identification

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

Predicate Devices

• A/C Enzymatic Homocysteine Assay on Hitachi 912 (K030754)

Submission Summary (Full Text)

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# 510(k) SUMMARY

## The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader

### Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

### 1. Submitter Information

Submitter: AntiCancer Inc. 7917 Ostrow Str. San Diego, California 92111 Phone: [phone] FAX: [phone] e-mail: (1) (2) (2) unticunder com

Yuying Tan, M.D. Contact Person: Principal Investigator of the Device Research Manager of AntiCancer Inc.

Date of Summary Preparation: March 24, 2008 Revised: Sep 16, 2008

### 2. Device Information

510K:#: k080851 Device Name: A/C Portable Enzymatic Homocysteine Assay Classification Name: Homocysteine Assay Class: II Product Code: LPS

### 3. Predicate Device Information

Device Name: A/C Enzymatic Homocysteine Assay on Hitachi 912 AntiCancer Inc. 7917 Ostrow Str. San Diego, California 92111 Phone: [phone] FAX: [phone] e-mail: http://www.bases.n 510(k) Number: K030754

Tan Y/510k/HCY Assay /510 k Summary (9/16/2008)

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### Information of Manufacturers 4.

### Kit Manufacturer

| Contract Manufacturer: | Bioserv Corporation<br>5340 Eastgate Mall<br>San Diego, CA 92121<br>Telephone: [phone]<br>FAX: [phone] |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| FDA Establishment Registration Number: | US FDA 2027352 |
| Contact Person : | Mary Richardson<br>Quality Assurance Manager |

### Reader Manufacturer

| Contract Manufacturer: | Wuxi Opulen Technologies Ltd. |
|------------------------|---------------------------------------------------------------|
| | 3-405, Originality Industrial Park |
| | Liyuan Economic Zone |
| | Wuxi, Jiangsu, 214072 |
| | P.R. China |
| | Telephone: [phone] |
| | FAX: [phone] |
| | Establishment Registration Number: 04707Q10000268, P.R. China |

Contact Person :

Jiasen Yan President

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#### ર. Statement of Intended Use

The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The AiC Enzymatic Homocysteine Assay is for in vitro diagnostic use.

### Description of Device 6.

The A/C Portable Enzymatic Homocysteine Assay is calibrated with A/C Enzymatic Homocysteine Assay Calibrators. A/C Enzymatic Homocysteine Assay Controls are assayed for the verification of the accuracy and precision of the A/C Portable Enzymatic Homocysteine Assay.

The A/C Enzymatic Homocysteine Assay measures tHCY. The principle of the assay is that after reduction, tHCY is depleted by Homocysteinase (rHCYase) and produces hydrogen sulfide (H2S), which is determined using N.N-dibutyl phenylene diamine (DBPDA), the combination of which forms a chromophore, the fluorescence is measured by the A/C Diagnostics Reader (HyTek-205).

The A/C Portable Enzymatic Homocysteine Assay is a three-steps reaction, which runs at room temperature. The total assay takes 80 minutes, and the A/C Diagnostics Reader is the only equipment needed.

### 7. Method Comparison

To establish equivalence to an existing device, and thus establish the safety and effectiveness. The A/C Portable Homocysteine Enzymatic Assay (K080851) on the A/C Diagnostics Reader is compared to the Predicate Device, the A/C Automatic Enzymatic HCY Assay on Hitachi 912 (K030754) {Table 1}.

The comparison of the A/C Portable Homocysteine Assay on the A/C Diagnostics Reader to the A/C Automatic Homocysteine Assay on the Hitachi 912 Automatic Analyzer [4-5] was carried for fifty plasma samples. The correlation and regression analysis yielded y = 1.01+0.91 with a correlation coefficient of R = 0.95. The distribution of the difference vs mean of paired tHCY values were shown in Bland-Altman plot. The mean difference between the two assays was 1.05 umol/L. The samples both at low and high concentrations of tHCY agreed well.

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## Table 1. Comparison of the A/C Portable Enzymatic HCY Assay and the A/C Automatic Enzymatic HCY Assay

| A/C Enzymatic<br>HCY Assay | | Differences | |
|----------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| | | K 080851<br>Portable HCY Assay | K 030754<br>Automatic HCY Assay |
| Similarities | Principle | Enzymatic | |
| | Indication for Use | The A/C Enzymatic Assay is intended for the quantitative<br>determination of total homocysteine (tHCY) in human<br>plasma or serum. The device can assist in the diagnosis<br>and treatment of patients suspected of having<br>hyperhomocysteinemia.<br>The assay is for <i>in vitro</i> diagnostic use. | |
| | Precision | CV for within assay ranged<br>from 3.8% to 4.8%.<br>CV for between assay<br>ranged from 5.0% to 7.4%. | CV for within assay ranged<br>from 3.0% to 4.8%.<br>CV for between assay<br>ranged from 4.9% to 7.8%. |
| Differences | Performance | Portable<br>Manual | Fully<br>Automatic |
| | Equipment | A/C Diagnostics Reader | Hitachi 912 Automatic<br>Analyzer |
| | Application | Small Lab | Large Lab and<br>Big Hospital |
| | High<br>throughput | 100 tests/hr | 360 tests/hr |

- K. 080851 Portable Assay: A/C Portable Enzymatic HCY Assay is the assay for current . 510k application.
- K 030754 Automatic Assay: A/C Automatic Enzymatic HCY Assay is the predicate . device, which 510k application has been cleared by FDA in 2003.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 0 2008

AntiCancer, Inc. c/o Yuying Tan, M.D. Research Manager 7917 Ostrow Road San Diego, CA 92111

Re: k080851 Trade Name: A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary Homocysteine Test System Regulatory Class: Class II Product Codes: LPS Dated: September 16, 2008 Received: September 25, 2008

Dear Dr. Tan:

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. Insting 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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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 not 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 tolli the [phone] or [phone] or at its Internet address str http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

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

Yéan 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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# Indications for Use

14080851 510(k) Number (if known):

Device Name:

Indications For Use:

ー

The A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The A/C Enzymatic Homocysteine Assay is for in vitro diagnostic use.

Prescription Use __ *_ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 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) | |
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| Divisic | |
| Off of In Vitro Diagnostic Device | |
| Evaluation and Safety | |
| Tan Y/510k/Hcy Assay/Indications for Use (8/14/2008) | |

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