N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins α--microglobulin in urine, IgA in CSF, IgG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.

Device Description

N/T Protein Control LC is a lyophilized control prepared from human urine and serum proteins with polygeline, rabbit albumin, and preservative. It is intended to be used as an accuracy control for the determination of human proteins in urine and CSF by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the N/T Protein Control LC device:

Important Note: The provided document is a 510(k) summary for a quality control material, not a diagnostic device that performs interpretations on patient data. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML diagnostic tools (like sensitivity, specificity, human reader performance, expert consensus, etc.) are not applicable to this type of device. The primary performance characteristic for a control material is its stability and its ability to provide known, consistent values for assay accuracy.

Acceptance Criteria and Device Performance for N/T Protein Control LC

Given that this is a quality control material, the primary "acceptance criteria" revolve around its stability and its ability to consistently produce expected values within a defined range when used with the specified systems. The document explicitly mentions stability.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Stability (Unopened)	Stable for at least 24 months at +2° to +8° C, as originally packaged.
Stability (Reconstituted)	Stable for at least 14 days at +2° to +8° C, once reconstituted.
Intended Use	As an assayed accuracy control for immunonephelometric and immunoturbidimetric determination of specific proteins (α1-microglobulin, IgA, IgG, transferrin, albumin, total protein) in urine and CSF using Behring Nephelometer Systems and TurbiTimeSystem.
Equivalence to Predicate	Substantially equivalent in intended use to N/T Protein Control UY (K955858). Both are lyophilized, multi-analyte controls with known concentrations of specific proteins.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a "test set" in the context of patient samples or a dataset for diagnostic performance. For a quality control material, the "test set" would typically refer to the batches of the control material manufactured and tested. The document only mentions "in-house protocols" for stability evaluation. No specific number of control vials or batches tested is provided.
Data Provenance: Not applicable in the traditional sense for a diagnostic device. The stability data would be generated internally by the manufacturer (Dade Behring Marburg GmbH) through laboratory testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This device is a quality control material, not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment based on clinical cases. Its "ground truth" (i.e., the expected concentration of an analyte) is established during its manufacturing and assaying process, typically against certified reference materials or established calibration methods.

4. Adjudication Method for the Test Set

Not Applicable. As this is a quality control material, there is no "adjudication" in the sense of resolving discrepancies in expert interpretations of patient data. The evaluation of its performance (e.g., stability) would be based on predefined analytical criteria and instrumental measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No. An MRMC comparative effectiveness study is not relevant for a quality control material. Such studies are designed to assess the impact of a diagnostic aid (like AI) on human reader performance, which doesn't apply here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No. This is not an algorithm-driven device. It is a consumable laboratory reagent.

7. The Type of Ground Truth Used

For a quality control material, the "ground truth" for the analyte concentrations in the control is established through analytical assaying using standardized methods and traceable calibrators. The product is "assayed" which means the manufacturer defines the expected ranges for the target proteins based on their internal testing and calibration. It is implied to be based on established analytical chemistry principles and potentially certified reference materials or primary standards for the relevant proteins.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of machine learning or AI for this product. The manufacturing process of a control material involves formulation, lyophilization, and subsequent quality control steps; it doesn't involve training an algorithm on a dataset.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the control values themselves is established through the manufacturing and assaying process against established analytical standards.

Summary

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510(k) Summarv For N/T Protein Control LC

1. Manufacture's Name, Address, Telephone, and Contact Person, Date of 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/T Protein Control LC:

Quality Control Material (assayed)

Classification Number: Class I (862.1660)

3. Identification of the Legally Marketed Device:

N/T Protein Control UY (K955858)

4. Device Description:

N/T Protein Control LC is a lvophilized control prepared from human urine and serum proteins with polygeline, rabbit albumin, and preservative. It is intended to be used as an accuracy control for the determination of human proteins in urine and CSF by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

5. Device Intended Use:

N/T Protein Control LC is intended for use as an assayed accuracy control for immunonephelometric determination of the proteins & - microglobulin in urine, IgA in CSF, IgG in CSF, transferrin in urine, albumin in urine and CSF, and total protein in urine and CSF using the Behring Nephelometer Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTimeSystem.

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

There are a number of in vitro diagnostic products that are used as quality control material to monitor the accuracy of immunology procedures. One such product is the N/T Protein Control UY (K955858). The N/T Protein Control LC is substantially equivalent in intended use to the N/T Protein Control UY. The N/T Protein Control LC, like the N/T Protein Control UY, is a lyophilized, multi-analyte control with known concentrations of specific proteins for control of nephelometric and turbidometric procedures.

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7. Device Performance Characteristics:

Stability:

Stability was evaluated according to in-house protocols and the control was found to be stable for at least 24 months at +2° to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once reconstituted.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle.

JUN 25 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714

K991704 Re: Trade Name: N/T Protein Control LC Regulatory Class: I Product Code: JJY 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 (QS) 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.

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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/cdrl/dsma/dsmamain.html".

Sincerely yours.

Steven Putman

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. N/T Protein Control LC 510(k) Notification

Indications for Use Statement

N/T Protein Control LC Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Clinical Laboratory
510(k) Number	K991704
Prescription Use	Over-The-Counter-Use
(Per 21 CFR 801.109)	(Optional Format 1-2-96)

Regulation Number and Section

§ 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.