K Number
K964062
Device Name
N PROTEIN STRANDARD SL
Date Cleared
1996-11-21

(42 days)

Product Code
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
N Protein Standard SL is intended to be used for the establishment of reference curves.
Device Description
The proposed standard, N Protein Standard SL is a standard 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) to establish reference curves for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Albumin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, IgG 3, Albumin α1-antitrypsin (α1-proteinase inhibitor) α2-macroglobulin Haptoglobin α1-acid glycoprotein Pre-albumin (transthyretin), laG 3, laG 4, B2-microalobulin, Ferritin, IGE.
More Information

Behring Nephelometer K860894, Behring Nephelometer 100 K892223, Behring Nephelometer II K943997

Behring Nephelometer K860894, Behring Nephelometer 100 K892223, Behring Nephelometer II K943997

No
The summary describes a standard for calibrating nephelometer systems and does not mention any AI or ML components.

No
The device is a standard used to establish reference curves for diagnostic tests, not to treat or cure a disease.

No.
The device is a reference standard used to establish calibration curves for Behring Nephelometer Systems, which are then used for testing various proteins. It is not directly used to diagnose a disease or condition in a patient.

No

The device description clearly states it is a liquid standard prepared from human serum, which is a physical substance, not software. It is intended for use with hardware nephelometer systems.

Based on the provided information, the N Protein Standard SL is an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is "for the establishment of reference curves" for various tests (IgG, IgA, IgM, etc.). These tests are performed on human serum, which is a biological specimen. Establishing reference curves is a crucial step in the quantitative measurement of analytes in these specimens.
  • Device Description: The device is a "standard prepared from human serum (liquid)" and is intended to be used "together with the Behring Nephelometer Systems" for specific tests. This clearly indicates its use in an in vitro diagnostic procedure.
  • Tests Performed: The list of tests (IgG, IgA, IgM, C3c, C4, etc.) are all common clinical laboratory tests performed on biological samples to diagnose or monitor various conditions.
  • Performance Studies: The inclusion of precision studies and stability data, along with key metrics like percent CVs, are typical for IVD devices to demonstrate their analytical performance.
  • Predicate Device: The mention of a predicate device ("N Protein Standard SY") further supports its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.

While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use, device description, and context of its use with diagnostic instruments for clinical tests on human specimens strongly align with the definition of an IVD.

N/A

Intended Use / Indications for Use

N Protein Standard SL is intended to be used for the establishment of reference curves.

Product codes

862.1150

Device Description

The proposed standard, N Protein Standard SL is a standard 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) to establish reference curves for the following tests: IgG, IgA, IgM, C3c, C4, Transferin, Albumin, Ceruloplasmin, RbP, Ig/L-chain, Kappa, Ig/L-chain, Lambda, IgG 1, IgG 2, IgG 3, Albumin alpha1-antitrypsin (alpha1-proteinase inhibitor) alpha2-macroglobulin Haptoglobin alpha1-acid glycoprotein Pre-albumin (transthyretin) IaG 3 IaG 4 B2-microalobulin Ferritin IGE

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

Precision studies using one lot of N Protein Standard SL were run on the Behring Nephelometer. The percent CVs ranged from 0.9 to 3.9 %. Stability was run according to in-house protocols and the standard was found to be stable for at least 12 months at +2 to +8℃, as originally packaged and for at least 15 days at +2 to +8°C, once opened.

Key Metrics

Not Found

Predicate Device(s)

N Protein Standard SY

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

0

Benring Diagnostics Inc. N Protein Standard SL 510(k) Notification

K964062

Inc.

ATTACHMENT 2

NOV 21 1996

510(k) SUMMARY FOR N PROTEIN STANDARD 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 |

Laura LeBarron Contact Person:

October 4, 1996 Date of Preparation:

Device Name/ Classification: 2.

N Protein Standard SL:calibrator
Classification Number:class II (862.1150)

Identification of the legally marketed device: 3.

N Protein Standard SY

Proposed Device Description: 4.

The proposed standard, N Protein Standard SL is a standard 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) to establish reference curves for the following tests:

IgGCeruloplasmin
IgARbP
IgMIg/L-chain, Kappa
C3cIg/L-chain, Lambda
C4IgG 1
TransferinIgG 2
AlbuminIgG 3

CONFIDENTIAL

000008

1

Albumin α1-antitrypsin (α1-proteinase inhibitor) α2-macroglobulin Haptoglobin α1-acid glycoprotein Pre-albumin (transthyretin)

laG 3 laG 4 B2-microalobulin Ferritin IGE

5. Proposed Device Intended Use:

N Protein Standard SL is intended to be used for the establishment of reference curves.

Medical device to which equivalence is claimed and comparison 6. information.

N Protein Standard SL is substantially equivalent in intended use to the N Protein Standard SY. Both standards are in vitro diagnostic reagents intended for use as a multi-constituent standard for the establishment of reference curves. The N Protein Standard SL, like the N Protein Standard SY, is a multiconstituent standard in a blood based matrix. Also, both standards are used for the calibration of immunology assays.

The N Protein Standard SL differs from the N Protein Standard SY in that the N Protein Standard SY is a lyophilized standard while the N Protein Standard SL is a liquid standard.

7. Proposed Device Performance Characteristics:

Precision and reproducibility:

Precision studies using one lot of N Protein Standard SL were run on the Behring Nephelometer. The percent CVs ranged from 0.9 to 3.9 %.

Stability

Stability was run according to in-house protocols and the standard was found to be stable for at least 12 months at +2 to +8℃, as originally packaged and for at least 15 days at +2 to +8°C, once opened.