N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine using the Behring Nephelometer Systems.

Device Description

N Protein Standard UY (lyophilized) is a standard prepared from human urinary proteins with polygeline and preservative. It is intended to establish reference curves for the quantitative determination of a - microglobulin by immunonephelometry with the Behring Nephelometer Systems (particle enhanced nephelometry).

AI/ML Overview

The provided text is a 510(k) summary for the N Protein Standard UY, a calibrator used for in-vitro diagnostic tests. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies or acceptance criteria in the manner that a specific diagnostic algorithm or device might. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Stability (Original Packaging)	Stable for at least 12 months at +2° to +8° C
Stability (Once Opened)	Stable for at least 14 days at +2° to +8° C
Intended Use Equivalence	Acknowledged as substantially equivalent to Protein Standard Urine Concentrate (K904254) for establishing reference curves for immunonephelometric determinations of α-microglobulin in urine using Behring Nephelometer Systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "Stability was evaluated according to in-house protocols," but does not detail the number of samples or test runs.
Data Provenance: Not specified. The manufacturer is Dade Behring Marburg GmbH, Germany, which suggests the study data might originate from Germany, but this is not explicitly stated. The study appears to be internal to the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This device is a calibrator, and its performance evaluation relates to its inherent stability and ability to function as a reference standard, not to diagnostic accuracy based on expert interpretation of biological samples.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As a calibrator, there is no expert adjudication process for its performance criteria in the way there would be for a diagnostic tool interpreting patient data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic device or a device involving human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a calibrator, not an algorithm. Its performance is evaluated independently as a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Internal Lab Standards/Reference Methods: For stability, the "ground truth" would be the expected concentrations/performance of the standard over time, tested against established laboratory methods and controls. The substantial equivalence claim is based on comparison to a legally marketed predicate device (Protein Standard Urine Concentrate).

8. The sample size for the training set

Not Applicable. This device is not an algorithm requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. This device is not an algorithm requiring a training set.

Summary

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JUL 15 1999

K991705

510(k) Summary For N Protein Standard UY

Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 76Marburg/Germany
Contact Information:	Dade Behring Inc.Glasgow SiteP.O. Box 6101Newark, Delaware 19714Attn: Rebecca S. AyashTel: 302-631-6276
Preparation date:	May 19, 1999

2. Device Name/ Classification:

N Protein Standard UY:

Calibrator

Class II (862.1150) Classification Number:

3. ldentification of the Legally Marketed Device:

Protein Standard Urine Concentrate (K904254)

Device Description: 4.

5. Device Intended Use:

N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine using the Behring Nephelometer Systems.

Medical device to which equivalence is claimed and comparison information: રે.
There are a number of in vitro diagnostic products that are used for the establishment of reference curves. One such product is the Protein Standard Urine Concentrate (K904254). The N Protein Standard UY is substantially equivalent in intended use to the Protein Standard Urine Concentrate. The N Protein Standard UY, like The Protein Standard Urine Concentrate is intended to be used for the calibration of an a1microglobulin assay on the Behring Nephelometer Systems.

7. Device Performance Characteristics:

Stability:

Stability was evaluated according to in-house protocols and the standard was found to be stable for at least 12 months at +2° to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once opened.

OOOUS

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JUL 15 1999

Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology DADE BEHRING INC. Glasglow Site P.O. Box 6101 Newark, Delaware 19714

Re: K991705 Trade Name: N Protein Standard UY Regulatory Class: II Product Code: JIT Dated: May 19, 1999 Received: May 19, 1999

Dear Ms. Ayash:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Dade Behring Inc. 510/k) Notification

K991705

Indications for Use Statement

N Protein Standard UY Device Name:

Indications for Use:

N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine using the Behring Nephelometer Systems.

Alan Cooper
(Division Sign-Off)
Division of Clinical Laboratory...vicx
510(k) Number K991705

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

000007

Regulation Number and Section

§ 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.