K Number
K021381
Device Name
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
Manufacturer
Date Cleared
2002-06-10

(40 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
N/T Rheumatology Controls are assayed controls for accuracy and precision in the quantitative determination of rheumatoid factors (RF), anti-streptolysin O (ASL) and C-reactive protein (CRP) in human serum using BN* Systems and the TurbiTimeSystem.
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 and precision of selected rheumatic and inflammatory disease with the BN and Behring TurbiTime Systems.
More Information

Not Found

No
The document describes assayed controls for laboratory tests and does not mention any AI or ML components.

No
The device is a quality control material intended to monitor the accuracy and precision of diagnostic tests, not to treat or modify a disease state.

No
This device is a quality control material used to monitor the accuracy and precision of diagnostic tests. It is not a diagnostic device itself.

No

The device is a quality control material for laboratory tests, which is a physical substance, not software.

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

Here's why:

  • Intended Use: The intended use explicitly states the device is for the "quantitative determination of rheumatoid factors (RF), anti-streptolysin O (ASL) and C-reactive protein (CRP) in human serum". This involves testing biological samples (human serum) outside of the body to provide information about a person's health status (related to rheumatic and inflammatory diseases).
  • Device Description: The description confirms it's a "quality control material to monitor the accuracy and precision of selected rheumatic and inflammatory disease" tests. Quality control materials for diagnostic tests are considered IVDs.
  • Predicate Device: The mention of a predicate device (K962373; N/T Rheumatology Controls SL 1 & 2) which is also a control material for similar tests further supports its classification as an IVD.

The core function of this device is to ensure the reliability of in vitro diagnostic tests performed on human samples.

N/A

Intended Use / Indications for Use

N/T Rheumatology Controls are assayed controls for accuracy and precision in the quantitative determination of rheumatoid factors (RF), anti-streptolysin O (ASL) and C-reactive protein (CRP) in human serum using BN* Systems and the TurbiTimeSystem.

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

JJY

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 and precision of selected rheumatic and inflammatory disease with the BN and Behring TurbiTime Systems.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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)

Stability was evaluated according to Dade Behring protocols and the control was found to be stable for at least 18 months at +2° to +8° C, as originally packaged and for at least 21 days at +2° to +8° C, once opened.

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.

K962373

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

0

/T Rheumatology Control 510(k) Response to Questions, K021381 May 30, 2002

JUN 1 0 2002

KO23881

510(k) Summary N/T Rheumatology Controls SL

  • Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
Manufacturer:Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
Marburg/Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Donna Wolf Tel: 302-631-0384

Preparation date: May 30, 2002

Device Name/ Classification: 2.

N/T Rheumatology Controls SL 1 & 2:Quality Control Material (assayed)
Classification Number:Class I (862.1660)

3. Identification of the Legally Marketed Device:

N/T Rheumatology Controls SL 1 & 2 (K962373)

4. 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 and precision of selected rheumatic and inflammatory disease with the BN and Behring TurbiTime Systems.

5. Device Intended Use:

N/T Rheumatology Controls are assayed controls for accuracy and precision in the quantitative determination of rheumatoid factors (RF), anti-streptolysin O (ASL) and C-reactive protein (CRP) in human serum using BN* Systems and the TurbiTimeSystem.

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

The N/T Rheumatology Controls SL (modified) is substantially equivalent to its predicate version (K962373). Modification of the intended use statement to include the use of Rheumatoid Factor determination with the TurbiTime System is the subject of this submission. Additionally, N/T Rheumatology Controls SL/2 will no longer be used for ADNase B determinations.

7. Device Performance Characteristics:

Stability:

Stability was evaluated according to Dade Behring protocols and the control was found to be stable for at least 18 months at +2° to +8° C, as originally packaged and for at least 21 days at +2° to +8° C, once opened.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them that resemble waves or ribbons.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 0 2002

Ms. Donna Wolf Senior Regulatory Affairs Specialist Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

Re: K021381

Trade/Device Name: N/T Rheumatology Controls SL Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material (assayed) Regulatory Class: I Product Code: JJY Dated: April 30, 2002 Received: May 1, 2002

Dear Ms. Wolf:

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. Iisting 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 the Code of Federal Regulations. Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Steven Sutman

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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N/T Rheumatology Control 510(k) Response to Questions, K021381 May 30, 2002

Indications for Use Statement

N/T Rheumatology Controls SL Device Name:

Indications for Use:

N/T Rheumatology Controls are assayed controls for accuracy and precision in the quantitative determination of rheumatoid factors (RF), anti-streptolysin O (ASL) and C-reactive protein (CRP) in human serum using BN* Systems and the TurbiTimeSystem.

Susan Altaie

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number_k 02 13 8

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use

(Optional Format 1-2-96)