(38 days)
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No
The document describes a protein control used for calibrating laboratory instruments and does not mention any AI or ML components.
No
The device is a control material used for quality assurance in diagnostic tests, not for directly treating a disease or condition.
No
The device, N/T Protein Control PY, is used for quality control of other diagnostic devices (Behring Nephelometer Systems and TurbiTimeSystem) when measuring specific proteins. It does not directly diagnose a patient's condition but rather ensures the accuracy and precision of diagnostic tests.
No
The device description clearly states it is a "lyophilized pool of citrate plasma," 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 it is used for "control of accuracy and precision in the quantitative immunochemical determination of alpha -- Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C+ Inhibitor". These are substances measured in biological samples (plasma) to provide information about a person's health.
- Device Description: The device is a "lyophilized pool of citrate plasma". Plasma is a biological sample.
- Function: The device is a "control" used in conjunction with other diagnostic systems (Behring Nephelometer Systems and TurbiTimeSystem) to ensure the accuracy and precision of the tests performed on patient samples. This is a key function of an IVD control.
The information provided clearly indicates that this device is intended to be used in vitro (outside the body) to analyze biological samples for diagnostic purposes.
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Intended Use / Indications for Use
N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha -- Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C+ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem. *not available in the U.S.
Product codes
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Device Description
The N/T Protein Control PY is a lyophilized pool of citrate plasma consisting of one level containing the following proteins: fibrinogen antithrombin III prothrombin plasminogen alpha 1 - Antitrypsin C1 Inhibitor
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Precision studies using multiple vials of the controls were run on the Behring Nephelometer. Ten vials of one lot were tested. Each of the parameters were determined in triplicate with each vial. The %CVs were calculated for each parameter. the %CVs ranged from 1.11 to 2.72%. Stability was run according to an in-house protocols and the control was found stable for at least 12 months lyophilized and 14 days once reconstituted.
Key Metrics
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Predicate Device(s)
Behring Diagnostic Inc., Control Plasma N
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7340 Fibrinogen determination system.
(a)
Identification. A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).(b)
Classification. Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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K 96 2407
Attachment 1
510(k) Summary of Safety and Effectiveness for Protein Control PY N/T
- Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
Behringwerke AG Manufacturer Postfach 1140 35001 Marburg Germany
| Distributor | Behring Diagnostics Inc. |
|---|---|
| 151 University Avenue | |
| Westwood, MA 02090 | |
| 617-320-3000 | |
| Attn: Kathleen Dray-Lyons |
Preparation date: June 20, 1996
Classification: 2. Device Name/
N/T Protein Control PY: Quality Control Material (assayed)
Classification Number: Class I (862.1660)
Identification of the legally marketed device: 3.
Behring Diagnostic Inc., Control Plasma N
Proposed Device Description: 4.
The N/T Protein Control PY is a lyophilized pool of citrate plasma consisting of one level containing the following proteins:
fibrinogen antithrombin III prothrombin plasminogen alpha 1 - Antitrypsin C1 Inhibitor
1
Proposed Device Intended Use: 5 .
N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha -- Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C+ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem.
*not available in the U.S.
Medical device to which equivalence is claimed and comparison 6 . information:
The N/T Protein Control PY is substantially equivalent in intended use to the Control Plasma N. Both products are in vitro diagnostic reagents intended for use as a quality control material to monitor certain laboratory coagulation and protein procedures. The N/T Protein Control PY like the Control Plasma N is single level protein control from a human blood-based matrix (citrate plasma). Both controls are provided with a lot specific table of values. The N/T Protein Control PY like the Control Plasma N is used for the following parameters; prothrombin, fibrinogen, plasminogen, C1 Inhibitor and antithrombin III. In addition, the N/T Protein Control PY contains alpha1-Antitrypsin. See Table I for comparative features and the attached N/T Protein Control PY draft package insert for specific product information.
The Behring Diagnostics N/T Protein Control PY differs from the Behring Control Plasma N in that the N/T Protein Control PY is a control for nephelometric coagulation and protein procedures while the Control Plasma N is a control for opto-mechanical and chromogenic coaqulation procedures.
7. Proposed Device Performance Characteristics:
Precision and reproducibility:
Precision studies using multiple vials of the controls were run on the Behring Nephelometer. Ten vials of one lot were tested. Each of the parameters were determined in triplicate with each vial. The %CVs were calculated for each parameter. the %CVs ranged from 1.11 to 2.72%.
Stability:
Stability was run according to an in-house protocols and the control was found stable for at least 12 months lyophilized and 14 days once reconstituted.
COGO 10
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Table I
COMPARATIVE FEATURES
N/T Protein Control PY vs Control Plasma N
| Feature | Control Plasma N | N/T Protein Control PY |
|---|---|---|
| 1. Human Blood- | ||
| Based Matrix | Yes | |
| (citrate plasma) | Yes | |
| (citrate plasma) | ||
| 2. Single Level | ||
| Control | Yes | Yes |
| 3. Multi-Constituent | ||
| Control | Yes | Yes |
| 4. Quality Control | ||
| Product | Yes | Yes |
| 5. Lyophilized | Yes | Yes |
| 6. Table of | ||
| Values Provided | Yes | Yes |
| 7. Coagulation | ||
| Control | Yes | Yes |
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