(27 days)
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No
The document describes a liquid control material for laboratory tests and does not mention any AI or ML components.
No
The device is described as a control for laboratory tests to ensure accuracy and precision in determining human serum proteins, not for treating any condition.
No
Explanation: The device is described as a "control prepared from human serum (liquid)" intended for "accuracy and precision controls in the determination of human serum proteins." It is used with other systems (Behring Nephelometer systems and TurbiTimeSystem™) as a control, not to directly diagnose a patient condition.
No
The device description clearly states it is a "control prepared from human serum (liquid) with stabilizers and preservative," indicating it 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's for "accuracy and precision controls in the determination of human serum proteins." This indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: The description confirms it's a control prepared from "human serum (liquid)" and is intended to be used with "Behring Nephelometer systems" and the "TurbiTimeSystem™" for various protein tests. These are all components and processes involved in in vitro diagnostic testing.
- Performance Studies: The performance studies describe precision testing using the control on the specified systems, which is a typical evaluation for IVD controls.
The device is a control material used to ensure the accuracy and reliability of in vitro diagnostic tests for human serum proteins. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.
Product codes
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Device Description
The proposed control, N/T Protein Control SL is a control prepared from human serum (liquid) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) and with the TurbiTimeSystem™ as accuracy and precision controls for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, Albumin, alpha1-antitrypsin (alpha1-proteinase inhibitor), 02-macroglobulin, Haptoglobin, alpha1-acid_αλνcoprotein, Pre-albumin (transthyretin), laG 3, laG 4, B2-microglobulin, Ferritin, laE.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision and reproducibility: Precision studies using one lot of N/T Protein Control SL were run on the Behring Nephelometer system and on the TurboTimeSystem™. The percent CV's ranged from 0.6 to 8.2 % on the Behring Nephelometer system and from 1.6 to 6.1 % on the TurbiTimeSystem™.
Stability: Stability was run according to in-house protocols and the control was found to be stable for at least 12 months at +2 to +8°C, as originally packaged and for at least 15 days at +2 to +8℃, once opened.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
Behring Nephelometer K860894, Behring Nephelometer 100 K892223, Behring Nephelometer II K943997
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Behring Diagnostics Inc. N/T Protein Control SL/L, M and H 510(k) Notification
NOV - 6 1996
ATTACHMENT 2
510(k) SUMMARY FOR N/T PROTEIN CONTROL SL
Manufactures Name, Address, Telephone, and contact person, date 1. of preparation:
Manufacture
Behringwerke AG Postfach 1140 35001 Marburg Germany
Distributor
Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3000
Contact Person:
Laura LeBarron
October 9, 1996 Date of Preparation:
2. Device Name/ Classification:
| N/T Protein Control SL: | quality control material |
|---|---|
| Classification Number: | class I (862.1660) |
3. Identification of the legally marketed device:
N/T Protein Control SY
4. Proposed Device Description:
The proposed control, N/T Protein Control SL is a control prepared from human serum (liquid) with stabilizers and preservative. It is intended to be used together with the Behring Nephelometer systems (Behring Nephelometer K860894, Behring Nephelometer 100 K892223 and the Behring Nephelometer II K943997) and with the TurbiTimeSystem™ as accuracy and precision controls for the following tests:
| IgG | Ceruloplasmin |
|---|---|
| IgA | RbP |
| IgM | Ig/L-chain, Kappa |
| C3c | Ig/L-chain, Lambda |
| C4 | IgG 1 |
| Transferin | IgG 2 |
Image /page/0/Picture/21 description: The image shows a sequence of seven characters. The first five characters appear to be zeros, although they are somewhat distorted and not perfectly formed. The sixth character is unclear, but the seventh character appears to be the number 3. The characters are all dark against a white background.
1
Albumin α1-antitrypsin (α1-proteinase inhibitor) 02-macroglobulin Haptoglobin α1-acid_αλνcoprotein Pre-albumin (transthyretin)
laG 3 laG 4 B2-microglobulin Ferritin laE
5. Proposed Device Intended Use:
N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.
6. Medical device to which equivalence is claimed and comparison information.
N/T Protein Control SL is substantially equivalent in intended use to the N/T Protein Control SY. Both controls are in vitro diagnostic reagents intended for use as multi-constituent accuracy and precision controls in the determination of human serum proteins. The N/T Protein Control SY, Ilke the proposed product, is a control in a blood based matrix. Also, both controls are used for accuracy and precision control in immunology assays.
The N/T Protein Control SL differs from the N/T Protein Control SY in that the N/T Protein Control SY is a lvophilized standard while the N/T Protein Control SL is a liquid control.
Proposed Device Performance Characteristics: 7.
Precision and reproducibility:
Precision studies using one lot of N/T Protein Control SL were run on the Behring Nephelometer system and on the TurboTimeSystem™. The percent CV's ranged from 0.6 to 8.2 % on the Behring Nephelometer system and from 1.6 to 6.1 % on the TurbiTimeSystem™.
Stability
Stability was run according to in-house protocols and the control was found to be stable for at least 12 months at +2 to +8°C, as originally packaged and for at least 15 days at +2 to +8℃, once opened.
CONFIDENTIAL