(16 days)
Not Found
No
The device description and lack of mentions of AI/ML terms or performance studies indicate it is a standard laboratory control material.
No
The device is described as a control serum for monitoring test procedures in cardiac marker determinations, not for treating any condition or disease.
No
This device is described as "control sera suitable for monitoring test procedures used in cardiac marker determinations." This indicates it's used to verify the accuracy of diagnostic tests, not to perform the diagnosis itself.
No
The device description clearly states it is a "ready-to-use liquid stable assayed control sera" prepared from a "human serum matrix," indicating it is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It is described as "control sera suitable for monitoring test procedures used in cardiac marker determinations." This clearly indicates its use in a laboratory setting to evaluate the performance of diagnostic tests.
- Predicate Device: The mention of a predicate device (K961828 LiquichekTM Cardiac Markers Control) which is also a control material for cardiac markers, further supports its classification as an IVD. Control materials are a common type of IVD used to ensure the accuracy and reliability of diagnostic tests.
The lack of information in other sections (like Intended Use/Indications for Use, performance studies, etc.) is common for control materials, as their primary function is to serve as a reference for other diagnostic tests, not to directly diagnose a condition in a patient.
N/A
Intended Use / Indications for Use
Not Found
Product codes
75JJT
Device Description
CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3 are ready-to-use liquid stable assayed control sera suitable for monitoring test procedures used in cardiac marker determinations. The controls are prepared from a human serum matrix with the addition of various constituents. Preservatives and stabilizers are added to maintain product integrity. The liquid matrix eliminates causes of vial to vial variability and, when handled as directed, provides consistency in day-to-day testing.
The controls are stable for 36 months from date of manufacture when stored unopened at -20°C. Unopened vials are stable for 60 days when stored at 2 - 8°C. Opened vials of control are stable for 30 days when stored tightly capped at 2 - 8°C.
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)
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
APR - 2 1997
Park · 542 Flynn Road · Camarillo, CA 93012-8058 phone: (805) 987-7891 · FAX: (805) 987-649
Image /page/0/Picture/2 description: The image shows the text "K970976" on the top line. The second line of text says "MEDICAL ANALYSIS SYSTEMS, INC." The text is white on a black background.
510(k) Notification · March 14,1997 CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3
510(k) SUBMISSION
CARDIOIMMUNE Cardiac Marker Control, is substantially Summary: equivalent to the existing LiquichekTM Cardiac Markers Control , (K961828) currently in commercial distribution by BIO-RAD.
Medical Analysis Systems CARDIOIMMUNE Cardiac Marker Control, Levels 1, 2 and 3 are ready-to-use liquid stable assayed control sera suitable for monitoring test procedures used in cardiac marker determinations. The controls are prepared from a human serum matrix with the addition of various constituents. Preservatives and stabilizers are added to maintain product integrity. The liquid matrix eliminates causes of vial to vial variability and, when handled as directed, provides consistency in day-to-day testing.
The controls are stable for 36 months from date of manufacture when stored unopened at -20°C. Unopened vials are stable for 60 days when stored at 2 - 8°C. Opened vials of control are stable for 30 days when stored tightly capped at 2 - 8°C.
Product Code: 75JJT
Image /page/0/Picture/9 description: The image shows three different certification logos. The first logo has the letters "BVQi" in a black square, followed by the text "ISO 9001" underneath. To the right of the square is a circular logo with a triangle inside. The second logo has the same "BVQi" and "ISO 9001" as the first logo, but it is followed by a logo with a crown on top of a check mark. The third logo has the same "BVQi" and "ISO 9001" as the first two logos, but it is followed by a triangle with a star inside a circle.