(17 days)
Not Found
Not Found
No
The document describes a control serum for monitoring assay conditions in a clinical laboratory setting. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The focus is on quality control for laboratory assays.
No
The device is described as an "assayed control serum" used for monitoring assay conditions in a clinical laboratory, which indicates it is a quality control product, not a therapeutic device.
No
The device is described as an "assayed control serum" intended for monitoring "assay conditions" and "assuring consistent performance of reagent and instrument" in a clinical laboratory. It is a control for other tests, not a diagnostic test itself.
No
The device is described as an "assayed control serum," which is a physical substance used in laboratory testing, not a software-only product.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assayed control bornmontions" and "monitoring assay conditions in specific assured oonly of our an of any and e DADE® Cardiac TL with patient serum carolac manel determinations". This indicates it's used in vitro (outside the body) to analyze samples (serum) for diagnostic purposes (monitoring assay performance for cardiac markers).
- Nature of the Device: It's described as an "assayed control serum". Control materials used in clinical laboratories to verify the accuracy and precision of diagnostic tests are a common type of IVD.
Therefore, the description strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MAS™ CardioImmune TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assayed control bornmontions. Include MAS™ Cardiolmmune TL with patient cardrac mance delemination for any of the listed constituents. Assay values scrant specific the specific systems listed. The user can compare observations are provided for the eas a means of assuring consistent performance of reagent and instrument.
The DADE® Cardiac TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assured oonly of our an of any and e DADE® Cardiac TL with patient serum carolac manel determinations: "In of the listed constituents. Assay values are Specifichs when assuring for any any any can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Product codes
JJY
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
Clinical laboratory
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): 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.
Not Found
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
DEC 21 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Penny M. Layman Regulatory Affairs Manager Medical Analysis Systems Inc. 5300 Adolfo Road Camarillo, CA 93012
K013995 Re:
R013995
Trade/Device Name: MAS™ CardioImmune TL Level 1, 2 and 3 and DADE® Cardiac TL Level 1, 2, and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: November 30, 2001 Received: December 4, 2001
Dear Ms. Layman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your 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, 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 (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.
1
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 1 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/odrh/dsma/dsmamain.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
2
INDICATIONS FOR USE FORM
Page 1 of 1
510(k) Number (if known): KO13995
Devicc Namc:
MAS™ CardioImmune TL Liquid Assayed Cardiac Marker Control Level 1, 2 and 3
DADE® Cardiac TL, Level 1and 2 Liquid Assayed Cardiac Marker Control Level 1, 2 and 3
Indications for Use:
The MAS™ CardioImmune TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assayed control bornmontions. Include MAS™ Cardiolmmune TL with patient cardrac mance delemination for any of the listed constituents. Assay values scrant specific the specific systems listed. The user can compare observations are provided for the eas a means of assuring consistent performance of reagent and instrument.
The DADE® Cardiac TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific assured oonly of our an of any and e DADE® Cardiac TL with patient serum carolac manel determinations: "In of the listed constituents. Assay values are Specifichs when assuring for any any any can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory 510(k) Number
(Optional Format 3-10-98)