(160 days)
Not Found
No
The document describes quality control materials for a protein assay and does not mention any AI or ML components.
No.
The device is described as an external quality control material to assist laboratories in monitoring the performance of the Triage Protein C Test, not for treating any medical condition.
No
Explanation: This device is described as a "control material" and "calibration verification control" used to monitor the performance and validate the performance of a separate "Triage Protein C Test." It is explicitly stated that these materials "are not calibrators and are not used to calibrate the Triage Protein C Test." It assists the laboratory in monitoring test performance and validating performance, not in diagnosing conditions in patients.
No
The device description clearly states the controls are "liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma," indicating a physical, biological product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the controls are "to be used with the Triage Protein C. Test to assist the laboratory in monitoring test performance" and "to validate the performance of the Triage Protein C Test". This indicates the device is used in vitro (outside the body) to evaluate the performance of another diagnostic test.
- Device Description: The description details the composition of the controls as "liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma". These are materials used to assess the accuracy and reliability of a diagnostic test.
- Intended User / Care Setting: The intended user is the "laboratory and professional use", which is typical for IVD devices used in a clinical laboratory setting.
- Summary of Performance Studies: The document describes performance studies conducted to evaluate the controls, which is a standard practice for IVD devices to demonstrate their reliability.
- Predicate Device(s): The listed predicate devices (Triage® BNP Controls and PrognostiX CardioMPO™ Control Kit) are also IVD control materials, further supporting the classification of this device as an IVD.
The device is a control material used in vitro to assess the performance of a diagnostic test, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
The Triage Protein C Controls are assayed materials to be used with the Triage Protein C Test to assist the laboratory in monitoring test performance.
The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX, GGN
Device Description
The Triage Protein C Control 1 and Control 2. and the Triage Protein C Calibration Verification Control Levels A, B and C are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. The controls are stored frozen at
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
510(k) Summary of Safety and Effectiveness B.
Triage® Protein C Test
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
K062840 The assigned 510(k) number is: __
Name and Address of Submitter 1.
Company Name: Address:
Totephone: Telefax:
Contact Person:
Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121 (858) 805-2722 (858) 586-7543
Fil V. Buenviaje Manager, Regulatory Compliance
Date Summary Prepared:
February 13, 2007
Controls
2. Device Name and Classification
Trade Name:
Common Name:
Triage® Protein C Controls and Triage® Protein C Calibration Verification
Protein C Controls; Single (Specified) Analyte Controls (Assayed and Unassayed)
Classification of Device:
21 CFR 862.1660, Quality Control Material (Assayed and Unassayed) Product Code: JJX
3. Predicate Devices
ter the state of the state of the states of the
Triage® BNP (B-Type Natriuretic Peptide) Controls (K000230) PrognostiX CardioMPO™ Control Kit (K050029)
1
4. Device Description
The Triage Protein C Control 1 and Control 2. and the Triage Protein C Calibration Verification Control Levels A, B and C are single-use, 0.25 mL unit dose liquid external quality control materials prepared with concentrated purified Protein C in human citrated plasma at defined levels. The controls are stored frozen at