K Number
K982591
Device Name
DADE TRU-LIQUID CARDIAC CONTROL
Manufacturer
Date Cleared
1998-08-05

(12 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedure, specifically Troponin-I, CK-MB and Myoglobin.
Device Description
Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).
More Information

Not Found

No
The summary describes a liquid quality control material for laboratory tests, with no mention of AI or ML in its intended use, device description, or any other section.

No
This device is described as a quality control material for laboratory procedures, not a device used for treating or diagnosing patients directly.

No
Explanation: The device is a quality control material used to assess the accuracy and precision of laboratory procedures, not to diagnose a patient's condition.

No

The device description clearly states it is a "Liquid Tri-Level Cardiac Control" and "Quality Control Material," indicating it is a physical substance, not software.

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

Here's why:

  • Intended Use: The intended use clearly states it's for "use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedure". This indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
  • Device Description: The description "Quality Control Material (Assayed and Unassayed)" further confirms its role in quality control for diagnostic procedures.
  • Intended User / Care Setting: The intended user is a "clinical laboratory", which is where IVD tests are performed.

Quality control materials like this are essential components of the IVD ecosystem, ensuring the reliability and accuracy of diagnostic results.

N/A

Intended Use / Indications for Use

Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedure, specifically Troponin-I, CK-MB and Myoglobin.

Product codes

JJX

Device Description

Not Found

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

Not Found

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

Not Found

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

Not Found

Predicate Device(s)

K981622

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

AUG - 5 1998

Image /page/0/Picture/1 description: The image shows a handwritten string of characters that appear to be alphanumeric. The characters are written in a cursive style, making it difficult to discern the exact letters and numbers. The string appears to be "K982591".

510(k) Summary of Safety and Effectiveness Information Dade® TRU-Liquid™ Cardiac Control July 25, 1998

Dade Behring Inc. 1851 Delaware Parkway Miami, FL 33125 Contact Person: John Cramer at (305) 637-6882, or by facsimile at (305) 637-6888.

| Trade or Proprietary Name: | Dade® TRU-Liquid™ Cardiac Control
Levels 1,2 and 3. |
|----------------------------|---------------------------------------------------------------|
| Common or Usual Name: | Liquid Tri-Level Cardiac Control |
| Classification Name: | Quality Control Material (Assayed and Unassayed) |
| Registration Number: | Manufacturer |
| | Dade Behring
1851 Delaware Parkway
Miami, Florida 33125 |

Registration Number 1017272

The Dade® TRU-Liquid™ Cardiac Control with expanded indications is substantially equivalent in terms of intended use and safety and effectiveness to the current Dade® TRU-Liquid™ Cardiac Control manufactured by Dade Behring, previously cleared under Document Control No., K981622.

1

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes coiled around it, and is often used as a symbol of medicine and healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 5 1998

Richard D. Bliss Vice President Quality Assurance and Regulatory Affairs Dade Behring 1851 Delaware Parkway Miami, Florida 33125

K982591 Re : Dade TRU-Liquid Cardiac Control Regulatory Class: I Product Code: JJX Dated: July 24, 1998 Received: July 24, 1998

Dear Mr. Bliss:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 regulations.

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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 (770) 488-7655.

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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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

3

510(k) Number (if known): Dade TRU-Liquid Cardiac Control

Device Name:

Indications For Use:

Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac market procedure, specifically Troponin-I, CK-MB and Myoglobin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K98259

OR

Over-The-Counter Use

1 Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)