N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2

K962373 · Behring Diagnostics, Inc. · DCK · Jul 11, 1996 · Immunology

Device Facts

• Record ID: K962373
• Device Name: N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
• Applicant: Behring Diagnostics, Inc.
• Product Code: DCK · Immunology
• Decision Date: Jul 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum using N Latex ASL and N Latex CRP mono Reagents or Turbiquant ASL and Turbiquant CRP respectively. In addition the product also serves as a accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B* (only in N/T Rheumatology Control SL/2) in human serum using N Latex RF and N Latex ADNase B Reagent respectively.

Device Story

N/T Rheumatology Controls SL1/2 are multi-constituent, bi-level liquid quality control materials. Used in clinical laboratories to monitor accuracy of nephelometric and turbidimetric assays (ASL, CRP, RF, ADNase B) on Behring Nephelometer (BN), BN-100, and Behring TurbiTimeSystem (TTS). Replaces individual lyophilized controls with a single-vial, multi-constituent liquid format. Healthcare providers use control results to verify assay performance and ensure accuracy of patient test results.

Clinical Evidence

Bench testing only. Accuracy studies performed on three Behring Nephelometers using two lots of controls and three lots of N Latex CRP mono reagent. Replicates of five. Percent recovery compared to assigned values ranged from 92.1% to 107.2%.

Technological Characteristics

Multi-constituent, bi-level liquid control serum. Designed for use with Behring Nephelometer (BN), BN-100, and Behring TurbiTimeSystem (TTS).

Indications for Use

Indicated for use as an in vitro diagnostic quality control material to monitor the accuracy of quantitative nephelometric and turbidimetric assays for ASL, CRP, rheumatoid factors, and ADNase B in human serum.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Predicate Devices

• N/T CRP Control Serum
• N/T RF Control Serum
• N/T ASL Control Serum

Submission Summary (Full Text)

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JUL 11 1996
K962373

# 510(k) Summary of Safety and Effectiveness for N/T Rheumatology Controls SL1/2

1. Manufactures Name, Address, Telephone, and contact person, date of preparation:

Manufacture
Behringwerke AG
Postfach 1140
35001 Marburg
Germany

Distributor
Behring Diagnostics Inc.
151 University Avenue
Westwood, MA 02090
617-320-3000
Attn: Kathleen Dray-Lyons

Preparation date: June 19, 1996

2. Device Name/ Classification:

N/T Rheumatology Control SL1/2: Quality Control Material (assayed)
Classification Number: class I (862.1660)

3. Identification of the legally marketed device:

N/T CRP, RF, and ASL Control Serum

4. Proposed Device Description:

N/T Rheumatology Controls SL (bi-level control; N/T Rheumatology Control SL/1 and N/T Rheumatology Control SL/2) is a multi-constituent control intended for use as a quality control material to monitor the accuracy of selected rheumatic and inflammatory disease with the Behring Nephelometer (BN), Behring Nephelometer 100 (BN-100) and the Behring TurbiTimeSystem® (TTS).

5. Proposed Device Intended Use:

Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum using N Latex ASL and N Latex CRP mono Reagents or Turbiquant ASL and Turbiquant CRP respectively.

In addition the product also serves as a accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B* (only in N/T Rheumatology Control SL/2) in human serum using N Latex RF and N Latex ADNase B Reagent respectively.

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

The N/T Rheumatology Controls SL are substantially equivalent in intended use to the individual N/T CRP Control Serum, N/T RF Control Serum and N/T ASL Control Serum. All products are *in vitro* diagnostic reagents intended for use as a quality control material to monitor the accuracy of certain immunology procedures. The N/T Rheumatology Controls SL, however, eliminates using three separate controls since all three constituents are included in one vial.

The N/T Rheumatology Controls SL differ from the N/T CRP Control Serum, N/T RF Control Serum and N/T ASL Control Serum in that the N/T Rheumatology Controls SL are liquid while the individual controls are lyophilized and the N/T Rheumatology Controls SL are bi-level while the individual controls are single-level.

7. Proposed Device Performance Characteristics:

Accuracy studies using multiple vials of the controls were run on three Behring Nephelometers. Two lots of each control were tested. Three lots of N Latex CRP mono reagent were assayed in replicates of five on the Behring Nephelometers. The mean values and the percent recovery from the assigned values were calculated for each parameter. The percent recoveries compared to assigned values ranged from 92.1 to 107.2%

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