TINA-QUANT HAPTOGLOBIN

K972639 · Boehringer Mannheim Corp. · DAD · Jan 9, 1998 · Immunology

Device Facts

• Record ID: K972639
• Device Name: TINA-QUANT HAPTOGLOBIN
• Applicant: Boehringer Mannheim Corp.
• Product Code: DAD · Immunology
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5460
• Device Class: Class 2

Intended Use

Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human serum and plasma. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobinhaptoglobin complexes and certain kidney diseases.

Device Story

Tina-quant® Haptoglobin Assay is an immunoturbidimetric assay for measuring haptoglobin levels in human serum or plasma. The assay uses a two-step process: sample is mixed with TRIS buffer (R1), followed by the addition of polyclonal anti-human haptoglobin antibodies (R2). Antibodies bind to haptoglobin, forming aggregates proportional to the haptoglobin concentration. The resulting turbidity is measured as an increase in optical density on a Hitachi instrument. The assay is intended for clinical laboratory use to assist in diagnosing hemolytic and kidney diseases. Results are used by clinicians to assess patient health status regarding hemoglobin-haptoglobin complex formation.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (intra-assay CV 2.5%, inter-assay CV 2.0%) and linearity (20-570 mg/dL). Method comparison against the predicate (N=98) showed strong correlation (r=0.982, Deming regression y=0.998x + 2.7). Interference testing confirmed no significant interference (≤ 10% error) from bilirubin (60 mg/dL), hemoglobin (500 mg/dL), lipemia (1500 mg/dL), or rheumatoid factor (2000 IU/mL).

Technological Characteristics

Immunoturbidimetric assay; utilizes polyclonal anti-human haptoglobin antibodies; TRIS buffer reagent; optical density measurement; requires Hitachi instrumentation; in vitro diagnostic use.

Indications for Use

Indicated for the quantitative in vitro determination of haptoglobin in human serum and plasma to aid in the diagnosis of hemolytic diseases and certain kidney diseases.

Regulatory Classification

Identification

A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

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 § 866.9.

Predicate Devices

• Behring BN® Haptoglobin assay

Reference Devices

• Partigen® Haptoglobin

Submission Summary (Full Text)

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Boehringer Mannheim Corporation Laboratory Diagnostics 2400 Bisso Lane
PO Box 4117
PO Box 4117
Concord CA 94524-4117 USA

Telephone: [phone] Fax: [phone]

K972639

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JAN - 9 1000

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### 510(k) Summary

**Introduction** According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| 1.<br>Submitter name, address, contact | Boehringer Mannheim Corporation<br>135 Sandberg Street<br>Thousand Oaks, CA 91360<br>(805) 241 - 7575<br><br>Contact Person: Mary Koning<br><br>Date Prepared: July 13, 1997 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 2.<br>Device name | Proprietary name: Tina-quant® Haptoglobin Assay<br><br>Common name: Immunoturbidometric assay for the determination of Haptoglobin.<br><br>Classification name: Haptoglobin immunological test system |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 3.<br>Predicate device | The Boehringer Mannheim Tina-quant® Haptoglobin is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring BN® Haptoglobin assay. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# 510(k) Summary, Continued

| 4.<br>Device<br>Description | The Haptoglobin determination is based upon turbidimetric immunoinhibition<br>(TINIA) using a serum or plasma blood sample. The sample containing<br>Haptoglobin is transferred into a TRIS buffer solution (R₁ reagent). In the<br>second step, an aliquot of solution of polyclonal anti-human Haptoglobin<br>antibodies (R₂ reagent) is added to mixture of the first step. The antibody will<br>bind to the Haptoglobin in the sample to form “aggregates” such that the<br>amount of aggregate formed is proportionate to the amount of Haptoglobin<br>present in the sample.<br><br>The resulting agglutination complex is measured turbidimetrically whereby<br>increased turbidity is reflected through an increase in optical density.<br>Therefore, the amount of Haptoglobin in the sample is directly proportional<br>to the amount of turbidity formed. |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.<br>Intended use | Immunoturbidometric assay for the quantitative in-vitro determination of<br>Haptoglobin. |
| 6.<br>Comparison<br>to predicate<br>device | The Boehringer Mannheim Tina-quant® Haptoglobin is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably it is substantially equivalent to the currently marketed<br>Behring BN® Haptoglobin assay. |
| | Continued on next page |

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## 510(k) Summary, Continued

6. Comparison to predicate device cont.

The following table compares the Tina-quant® Haptoglobin with the The following table compares the Tima quain o suy. Specific data on the predicate device, Deliming DNG Traptograted into the draft labeling in performance of the test have occh moorporated in attachment 6.

#### Similarities:

•Intended Use: Immunoassay for the in vitro quantitative determination of Haptoglobin

•Sample type: Serum and plasma

| Differences: | | |
|----------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------|
| Feature | Tina-quant® Haptoglobin | Behring BN® Haptoglobin |
| Reaction test<br>principle | Immunoturbidimetric | Latex bound antigen/antibody<br>causing visible agglutination<br>through large immune complex<br>formation. |
| Instrument<br>required | Hitachi | Behring Nephelometer (BN) |

#### The Co

#### Performance Characteristics:

| Feature | Tina-quant® Haptoglobin | Behring BN® Haptoglobin |
|-----------------------|-------------------------------|-------------------------------|
| Precision | Intra and InterAssay (ng/ml): | Intra and InterAssay (mg/dL): |
| | | |
| | | |
| | | |
| Level | Pool | |
| | Low | |
| | High | |
| N | 21 | 30 |
| Intra-Assay Mean | 167.1 | 188 |
| %CV | 2.5 | 2.5 |
| Level | Sample 1 | |
| | Sample 2 | |
| N | 21 | 10 |
| Inter-Assay Mean | 27.9 | 185 |
| %CV | 2.0 | 3.0 |
| Lower Detection Limit | 5 mg/dL | --- |

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# 510(k) Summary, Continued

6.

## Performance Characteristics:

Comparison to predicate device, (cont.)

| Feature | Tina-quant® Haptoglobin | Behring BN®Haptoglobin |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Linearity | 20 - 570 mg/dL | --- |
| Method<br>Comparison | Vs Behring BN®<br>Haptoglobin<br>Deming's<br>$y =0.998x + 2.7$<br>$r=0.982$<br>$SEE=10.97$<br>$N=98$<br><br>Least Squares:<br>$y = 0.981x + 5.5$<br>$r = 0.982$<br>$SEE = 15.36$<br>$N = 98$ | Vs Partigen® Haptoglobin<br><br>Linear Regression<br>$y =1.01x - 11$<br>$r=0.96$<br>$N=30$ |
| Interfering<br>substances | No interference at:<br>(≤ 10% error)<br><br>Bilirubin 60 mg/dL<br>Hemoglobin 500 mg/dL<br>Lipemia 1500 mg/dL<br>Rheumatoid<br>Factor 2000 IU/mL | --- |
| Specificity | Specific for haptoglobin | Specific for haptoglobin |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 9 1998

Ms. Mary Koning Regulatory Affairs Specialist Boehringer Mannheim Corporation 135 Sandberg Street Thousand Oaks, California 91360

Re : K972639/S1 Trade Name: Tina-quant® Haptoglobin Assay Requlatory Class: II Product Code: DAD Dated: October 20, 1997 Received: October 22, 1997

Dear Ms. Koning:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972639

Device Name: Tina-quant® Haptoglobin Assay

Indications For Usc:

Intendcd usc

Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human scrum and plasma.

Mcasurement of haptoglobin may aid in the diagnosis of hemolytic discases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobinhaptoglohin complexes and ccrtain kidncy discascs.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

Peter E. Maksim
(Line Sign-Off) ratory Devices KA72639

(Division Sign-Off)
Division of Clinical Labor
510(k) Number