N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H

K052788 · Dade Behring, Inc. · LPS · Mar 29, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052788
• Device Name: N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
• Applicant: Dade Behring, Inc.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

N Latex HCY: In vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry on the BN™ II and BN ProSpec® Systems. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. N Protein Standard SL: Establishment of reference curves for the determination of IgG, IgG14, IgA, IgM, IgE, C3c, C4, transferrin, albumin, α-antitrypsin, α--macroglobulin, haptoglobin, α -- acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, (g/L-chain lambda & kappa, soluble transferrin receptor, ferritin, ß2-microglobulin, total protein and homocysteine by immunonephelometry with BN™ Systems. N/T Protein Control SL/L, M and H: N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, IgGr.4, IgM, C3c, C4, transferrin, albumin, αγ-antitrypsin, α--macroglobulin, haptoglobin, α--acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2-microglobulin, soluble transferrin receptor, ferritin, IgE, total protein and homocysteine.

Device Story

In vitro diagnostic reagent kit for quantitative determination of total homocysteine in human serum/plasma. Input: patient serum/plasma samples. Principle: particle-enhanced immunonephelometry; bound homocysteine reduced to free form via dithiothreitol; enzymatically converted to S-adenosyl-homocysteine (SAH). Conjugated S-adenosyl-cysteine (SAC) competes with sample SAH for binding to anti-SAH antibodies on polystyrene particles. Presence of SAH inhibits particle aggregation; absence of SAH allows aggregation. Output: scattered light signal inversely proportional to SAH concentration; evaluated against reference standard. Used in clinical laboratories on BN II and BN ProSpec systems. Results assist clinicians in diagnosing and managing hyperhomocysteinemia and homocystinuria.

Clinical Evidence

No clinical studies performed. Evidence consists of analytical bench testing. Method comparison study (n=87) against predicate device yielded regression y = 0.97x + 0.01 (r=0.99). Precision studies (CLSI EP5-A2) showed within-run CV 2.7-4.6% and total CV 4.6-8.5%. Linearity confirmed with 90.5-103.2% recovery. Specificity testing showed <10% cross-reactivity for related compounds; no interference from bilirubin, hemoglobin, lipids, or rheumatoid factors.

Technological Characteristics

Particle-enhanced immunonephelometry assay. Reagents: polystyrene particles coated with mouse monoclonal anti-SAH antibody, dithiothreitol (reduction), S-adenosyl-L-homocysteine hydrolase (enzyme), and PTG-SAC conjugate. Energy source: BN™ II/BN ProSpec® optical system (nephelometry). Connectivity: System-integrated. Sterilization: Not applicable (reagents). Software: Embedded system control.

Indications for Use

Indicated for patients suspected of having hyperhomocysteinemia and homocystinuria to assist in diagnosis and treatment monitoring via quantitative determination of total homocysteine in human serum, heparinized plasma, and EDTA plasma.

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 Assay (K992858)

Submission Summary (Full Text)

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# MAR 2 9 2006

# 510(k) Summary for N Latex HCY

This summary of 510(k) 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: k052788

### Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

Distributor: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 D-35001 Marburg, Germany Dade Behring Inc. Contact Information: Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone] March 14, 2006 Preparation date: Device Name N Latex HCY N Protein Standard SL N/T Protein Control SL/L, M and H Classification: Class II; Class II; Class I

21 CFR 862.1377; 862.1150; 862.1660 Clinical Chemistry (75) LPS; JIT; JJX Product Code:

#### 3. Identification of the Legally Marketed Device:

2.

Panel:

Abbott IMx Homocysteine Assay - K992858

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#### 4. Device Description:

Bound homocysteine in the sample is reduced to free homocysteine by the action of dithiothreitol, and converted enzymatically to S-adenosyl-homocysteine (SAH) in the next step. Conjugated S-adenosyl-cysteine (SAC), added at the onset of the reaction, competes with the SAH in the sample for bonding by anti-SAH antibodies bound to polystyrene particles. In the presence of SAH, there is either no aggregation or a weaker aggregation of particles. In the absence of SAH in the sample, an aggregation of the polystyrene particles by the conjugated SAC occurs. The higher the SAH content of the reaction mixture is, the smaller the scattered light signal. The result is evaluated by comparison with a standard of known concentration.

#### 5. Device Intended Use:

### N Latex HCY:

In vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry on the BN™ II and BN ProSpec® Systems. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

## N Protein Standard SL:

Establishment of reference curves for the determination of IgG, IgG14, IgA, IgM, IgE, C3c, C4, transferrin, albumin, α-antitrypsin, α--macroglobulin, haptoglobin, α -- acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, (g/L-chain lambda & kappa, soluble transferrin receptor, ferritin, ß2-microglobulin, total protein and homocysteine by immunonephelometry with BN™ Systems.

### N/T Protein Control SL/L, M and H:

N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, IgGr.4, IgM, C3c, C4, transferrin, albumin, αγ-antitrypsin, α--macroglobulin, haptoglobin, α--acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2-microglobulin, soluble transferrin receptor, ferritin, IgE, total protein and homocysteine.

#### 6. Medical device to which equivalence is claimed and comparison information:

The N Latex HCY assay is substantially equivalent to the Abbott IMx Homocysteine assav

(K992858). The N Latex HCY assay, like the Abbott IMx Homocysteine assay is intended for use in the quantitative determination of total homocysteine (HCY) in human serum or plasma.

#### 7. Device Performance Characteristics:

The N Latex HCY was compared to the Abbott IMx HCY assay by evaluating 73 plasma samples with concentrations ranging from 4.83 to 38.40 umol/L. Regression analysis of the results yielded the following equation:

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| N Latex HCY | (n=) | Slope | Intercept | Correlation Coefficient |
|-------------|------|-------|-----------|-------------------------|
| | 73 | 0.97 | 0.06 | 0.99 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted with three curved lines representing its body and wings.

Public Health Service

MAR 2 9 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Bldg 500 P.O. Box 6101 Newark, DE 19714-6101

Re: k052788

> Trade/Device Name: N Latex HCY N Protein Standard SL N/T Protein Control SL Regulation Number: 21 CFR8862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II Product Code: LPS, JIX, JJY Dated: February 17, 2006 Received: February 21, 2006

Dear Ms. Dray- Lyons:

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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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 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto Guti

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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Dade Behring Inc. 510(k) Notification

# Indications Statement

Device Name:

N Latex HCY N Protein Standard SL N/T Protein Control SL

Indications for Use:

Kos 2188

### N Latex HCY:

In vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry on the BN™ II and BN ProSpec® Systems. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

### N Protein Standard SL:

Establishment of reference curves for the determination of IgG, IgG, 4, IgA, IgM, IgE, C3c, C4, transferrin, albumin, α-antitrypsin, α--macroglobulin, haptoglobin, α--acid giyooprotein, grealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lambda & kappa, soluble transferrin receptor, ferritin, }>>microglouli, total protein and homocysteine by immunonephelometry with BN™ Systems.

### N/T Protein Control SL/L, M and H:

N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BNI™ Systems: IgG, IgG; 4, IgM, C3c, C4, transferrin, albumin, α;-antitrypsin, α₂-macroglobulin, haptoglobin, α - acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lamhda & Rogioa, βmicroglobulin, soluble transferrin receptor, ferritin, IgE, total protein and homocysteine.

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use (21 CFR 801)

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

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

Carol Benom
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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K052188