(38 days)
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.
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
Below is an analysis of the provided text regarding acceptance criteria and study details for the "N/T Protein Control PY" device. Please note that the document primarily focuses on demonstrating substantial equivalence and provides limited information typically found in a comprehensive medical device performance study, especially for AI-based devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a quality control material and focuses on its precision and stability, rather than diagnostic accuracy against a specific condition. Therefore, typical acceptance criteria like sensitivity, specificity, or AUC are not applicable here. The acceptance criteria for this type of device generally revolve around its ability to provide consistent and stable control values.
| Acceptance Criteria Category | Specific Criteria/Metric | Target (Acceptance Criteria) | Reported Device Performance |
|---|---|---|---|
| Precision | %CV (Coefficient of Variation) | Not explicitly stated as a target, but lower %CV is better indicating high precision. | Ranged from 1.11% to 2.72% for various parameters. |
| Stability (Lyophilized) | Duration of stability | Not explicitly stated as a target, but longer stability is better. | At least 12 months |
| Stability (Reconstituted) | Duration of stability | Not explicitly stated as a target, but longer stability is better. | 14 days |
Note: The document does not explicitly state numerical "acceptance criteria" for precision or stability (e.g., "%CV must be < X%"). Instead, it reports the observed performance characteristics. For a quality control material, the expectation is that these values demonstrate suitability for their intended use in monitoring laboratory procedures.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Precision Study: "Ten vials of one lot were tested."
- Stability Study: Not explicitly stated, but typically involves a series of measurements over time, possibly using multiple vials from different lots.
- Data Provenance: Not explicitly stated (e.g., country of origin). The manufacturer is based in Germany, and the distributor in the USA. Given this is a lab control material, the data likely comes from internal laboratory testing.
- Retrospective or Prospective: These studies (precision and stability) are prospective internal laboratory studies conducted to characterize the product's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for this device. The N/T Protein Control PY is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth. Its "ground truth" is its inherent concentration of the specified proteins, which is determined through reference methods and internal standardization by the manufacturer. The "truth" being evaluated in the studies is the device's ability to consistently provide these known values.
4. Adjudication Method for the Test Set
Not applicable. As stated above, this is a quality control material, not a diagnostic device requiring expert adjudication for establishing a "ground truth" based on clinical cases. The "results" are quantitative measurements of protein concentrations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. The N/T Protein Control PY is a laboratory reagent; there are no "readers" in the context of interpreting clinical cases.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable in the typical sense of an AI algorithm. This device is a consumable reagent used in analytical instruments (Behring Nephelometer Systems and TurbiTimeSystem). Its "performance" is its intrinsic chemical stability and measurement consistency, not an algorithm's output. The instrument itself performs the detection.
7. The Type of Ground Truth Used
The "ground truth" for the N/T Protein Control PY is the assigned target values (concentrations) of the various proteins (fibrinogen, antithrombin III, etc.) within the control material. These values are established by the manufacturer through rigorous analytical methods and are provided with each lot (as indicated by "Table of Values Provided"). The studies aim to demonstrate that the device measures these known ground truth values consistently and stably.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent and not an AI algorithm that requires a training set. The concept of a "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no training set for this type of device, the method of establishing ground truth for it is irrelevant.
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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
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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 LevelControl | Yes | Yes |
| 3. Multi-ConstituentControl | Yes | Yes |
| 4. Quality ControlProduct | Yes | Yes |
| 5. Lyophilized | Yes | Yes |
| 6. Table ofValues Provided | Yes | Yes |
| 7. CoagulationControl | Yes | Yes |
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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.