HEMOSIL HOMOCYSTEINE AND CONTROLS

K061598 · Instrumentation Laboratory CO · LPS · Sep 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061598
• Device Name: HEMOSIL HOMOCYSTEINE AND CONTROLS
• Applicant: Instrumentation Laboratory CO
• Product Code: LPS · Clinical Chemistry
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria. HemosIL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemosIL Homocysteine on IL Coagulation Systems. For in vitro diagnostic use.

Device Story

HemosIL Homocysteine is an automated latex-enhanced immunoassay used on IL Coagulation Systems (e.g., ACL TOP, ACL Futura) to measure total L-homocysteine in citrated plasma. The process involves three stages: reduction of protein-bound/disulfide homocysteine to free homocysteine; enzymatic conversion to S-adenosyl-L-homocysteine (SAH) using SAH hydrolase and excess adenosine; and competitive agglutination between anti-SAH monoclonal antibody-coated latex particles and the generated SAH. The degree of agglutination is inversely proportional to homocysteine concentration, measured via light transmission decrease. The device is used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing hyperhomocysteinemia and homocystinuria. The system provides automated dilution for samples exceeding the linear range, improving workflow efficiency and diagnostic accuracy.

Clinical Evidence

Method comparison study of 76 paired sodium citrate and EDTA patient plasma samples (range 4.2–56.7 µmol/L) showed correlation (r=0.9915, slope 0.8292) against predicate. Precision assessed across multiple IL Coagulation Systems (ACL Advance, ACL TOP, ACL ELITE/ELITE PRO) using two control levels and plasma samples; total CV% ranged from 3.5% to 6.2%.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents include PBS buffer, TCEP reductant, SAH hydrolase enzyme, and polystyrene latex particles coated with anti-SAH monoclonal antibody. Operates on IL Coagulation Systems (ACL TOP, ACL Futura, ACL 9000). Quantitative measurement via light transmission. Calibrated using SAH in PBS. Standardized per CLSI guidelines (EP5-A, EP7-A, H21-A4).

Indications for Use

Indicated for the quantitative determination of total L-homocysteine in human citrated plasma to assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria.

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

• Abbott IMx Homocysteine (k992858)

Submission Summary (Full Text)

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Ka61598

# 510(k) Summary HemosIL Homocysteine and HemosIL Homocysteine Controls

### Submitted by:

Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421

## Contact Information:

Carol Marble, Regulatory Affairs Director Phone: [phone] Fax: [phone] [e-mail] E-mail:

### Summary Prepared:

June 7, 2006

Section 5

### Device Trade Name:

HemosIL Homocysteine HemosIL Homocysteine Controls

### Regulatory Information:

| 862.1377 | Urinary homocysteine (nonquantitative) test system | |
|----------|-------------------------------------------------------------|----------|
| LPS | | Class II |
| 862.1660 | Single (specified) analyte controls (assayed and unassayed) | |
| JJX | | Class I |

## Identification of Predicate Device:

K992858 Abbott IMx Homocysteine

## Device Intended Use and Description:

HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems. Homocysteine (Hcy) values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria.

HemosIL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemosIL Homocysteine on IL Coagulation Systems.

Hey levels in patient plasma are measured automatically on IL Coagulation Systems in three stages:

- 1. Reduction of mixed disulfides and protein-bound forms of Hcy present in the plasma samples to free Hcy.
- 2. Enzymatic conversion of free Hcy to S-adenosyl-L-homocysteine (SAH) by the SAH hydrolase (SAHH) in the presence of an excess of adenosine.
- 3. Competitive agglutination reaction between anti-SAH and SAH / conjugate.

The degree of agglutination is inversely proportional to the concentration of total Hev in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.

HemosIL Homocysteine Kit and Controls 510(k)

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SEP 2 2 2006

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# 510(k) Summary HemosIL Homocysteine and HemosIL Homocysteine Controls

## Statement of Technological Characteristics of the Device Compared to Predicate Device:

HemosIL Homocysteine is substantially equivalent to the commercially available predicate device (Abbott IMx Homocysteine) in performance and intended use.

### Summary of Performance Data:

### Method Comparison

In a method comparison study evaluating 76 paired sodium citrate and EDTA patient plasma samples with homocysteine levels ranging from 4.2 to 56.7 umol/L, the correlation statistics for HemosIL Homocysteine (sodium citrate plasma) versus the predicate device (EDTA plasma) are shown below:

| IL System | Slope | Intercept | r |
|-------------|--------|-----------|--------|
| ACL Advance | 0.8292 | 0.3503 | 0.9915 |

### Precision

Within run and total precision assessed over multiple runs using two control levels and a plasma sample gave the following results:

| ACL TOP | Mean (µmol/L) | CV% (Within run) | CV% (Total) |
|-----------------------------------|---------------|------------------|-------------|
| Hcy Control Level 1 | 11.4 | 2.0 | 4.8 |
| Hcy Control Level 2 | 22.4 | 1.5 | 3.5 |
| Hcy Plasma Sample | 8.1 | 2.9 | 5.5 |
| ACL ELITE/ELITE PRO/<br>8/9/10000 | Mean (µmol/L) | CV% (Within run) | CV% (Total) |
| Hcy Control Level 1 | 12.3 | 2.3 | 5.1 |
| Hcy Control Level 2 | 22.8 | 4.3 | 6.2 |
| Hcy Plasma Sample | 8.4 | 2.6 | 5.9 |
| ACL Futura/ACL Advance | Mean (µmol/L) | CV% (Within run) | CV% (Total) |
| Hcy Control Level 1 | 10.5 | 3.5 | 6.0 |
| Hcy Control Level 2 | 21.1 | 2.6 | 3.5 |
| Hcy Plasma Sample | 7.9 | 3.5 | 5.6 |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Instrumentation Laboratory Company 113 Hartwell Ave. Lexington MA 02421

SEP 2 2 2006

Re: k061598

> Trade/Device Name: Hemosit Homocysteine and HemosIL Homocysteine Controls Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II Product Code: LPS, JJX Dated: August 21, 2006 Received: August 22, 2006

Dear Ms. Marble:

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 wotification" (21 CFR 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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Gutierrez, Ph.D. 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 Statement

510(k) Number (if known): Kob 1598

Device Name:

HemosIL Homocysteine and HemosIL Homocysteine Controls

Indications for Use:

HemosIL Homocysteine is an automated latex enhanced immunoassay for the quantitative determination of total L-homocysteine in human citrated plasma on IL Coagulation Systems. Homocysteine (Hcy) values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia or homocystinuria.

HemosIL Homocysteine Controls are assayed quality controls intended to monitor the accuracy and precision of HemosIL Homocysteine on IL Coagulation Systems.

For in vitro diagnostic use.

V Prescription Use (Part 21 CFR 801 Subpart D)

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)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K06 1598

HemosIL Homocysteine Kit and Controls 510(k)

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