K Number
K962373
Device Name
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
Date Cleared
1996-07-11

(21 days)

Product Code
Regulation Number
866.5270
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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).
More Information

Not Found

None

No
The document describes a quality control material for laboratory tests and does not mention any AI or ML components.

No
The device is a quality control material used to monitor the accuracy of diagnostic tests for rheumatic and inflammatory diseases. It does not directly treat or diagnose a condition in a patient.

No

The device is a quality control material used to monitor the accuracy of tests for rheumatic and inflammatory diseases, not a diagnostic device itself.

No

The device description clearly states it is a "multi-constituent control intended for use as a quality control material". This indicates a physical substance used for calibration or verification, not a software-only product. The performance studies also describe testing "multiple vials of the controls," further confirming it is a physical material.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states "Accuracy control of the quantitative nephelometric and turbidimetric determination of ASL and CRP in the human serum..." and "accuracy control of the quantitative nephelometric determination of rheumatoid factors, and ADNase B... in human serum". This indicates the device is used to evaluate the performance of other diagnostic tests that analyze human biological samples (serum).
  • Device Description: The description states it is a "multi-constituent control intended for use as a quality control material to monitor the accuracy of selected rheumatic and inflammatory disease" tests. Quality control materials used to assess the accuracy of diagnostic tests are a key component of IVD systems.
  • Sample Type: The device is used with "human serum", which is a biological sample.
  • Purpose: The purpose is to ensure the accuracy of other diagnostic tests, which is a fundamental aspect of in vitro diagnostics.

The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

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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) .

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

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Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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%

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 866.5270 C-reactive protein immunological test system.

(a)
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.(b)
Classification. Class II (performance standards).

0

JI | 1996

K962373

0000000

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

  • Manufactures Name, Address, Telephone, and contact person, date of 1 . 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 (assaved) class I (862.1660) Classification Number:

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:

ﻤﺴﺘﻘﻠﺔ

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.

1

Medical device to which equivalence is claimed and comparison 6 . . 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%