N/T Protein Control LC is intended for use as an assayed accuracy and precision control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and a - microglobulin in urine, albumin and total protein in urine and CSF using the BN™ Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTime System.

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 BN™ Systems and by immunoturbidimetry with the TurbiTimeSystem.

AI/ML Overview

The provided text describes a 510(k) Notification-Modification for Dade Behring Inc.'s N/T Protein Control LC. This is a quality control material, not a medical device in the typical sense that would diagnose or treat a condition, and as such, the performance criteria and supporting data differ significantly from what would be expected for an AI-powered diagnostic device.

Therefore, many of the typical questions for AI acceptance criteria (like effect size with AI assistance, expert qualifications, adjudication methods, training set details) are not applicable to this type of device.

Here's the information that can be extracted and a clear indication of what is not applicable:

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

Acceptance Criteria	Reported Device Performance
Stability (unopened)	Stable for at least 24 months at +2° to +8° C
Stability (reconstituted)	Stable for at least 14 days at +2º to +8º C

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated in terms of a "test set" for performance evaluation in the way a diagnostic device would typically have. The stability was evaluated "according to in-house protocols," implying internal testing rather than a large, independent clinical test set.
Data Provenance: The stability evaluation was done "according to in-house protocols" by Dade Behring Marburg GmbH and Dade Behring Inc. This indicates internal, company-generated data. It's likely prospective testing conducted in a laboratory setting. No country of origin for external data is mentioned as it's an internal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a quality control material. Ground truth for its performance would be established by analytical methods and reference standards for stability, not by expert consensus on clinical findings.

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

Not Applicable. See point 3.

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-powered diagnostic device; it's a quality control material.

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

Not Applicable. This is not an algorithm or AI device. Its performance is inherent to its chemical composition and manufacturing control.

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

Analytical Standards/Internal Protocols: The ground truth for stability would be based on established analytical chemistry methods and internal stability protocols, comparing the control's performance over time against its initial validated values using specified instrumentation (BN™ Systems and TurbiTimeSystem).

8. The sample size for the training set

Not Applicable. This product is not an AI algorithm that requires a "training set."

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

Not Applicable. See point 8.

Summary

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K032237

Dade Rehring Inc N/T Protein Control LC 510(k) Notification-Modification

SEP - 5 2003

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

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

Manufacturer: Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany Dade Behring Inc. Contact Information: Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn:Kathleen Dray-Lyons Tel: 781-826-4551 Preparation date: July 18, 2003

2. Device Name/ Classification:

N/T Protein Control LC: Quality Control Material (assaved)

Classification Number: Class I (862.1660)

Identification of the Legally Marketed Device: 3.

N/T Protein Control LC (K991704)

4. Device Description:

1. Device Intended Use:
  N/T Protein Control LC is intended for use as an assayed accuracy and precision control for immunochemical determination of IgA, IgG and IgM in CSF, transferrin and aqmicroglobulin in urine, albumin and total protein in urine and CSF using the BN™ Systems and also for IgG in CSF and albumin in urine and CSF, using the TurbiTime System.
1. Medical device to which equivalence is claimed and comparison information: The modified N/T Protein Control SL is substantially equivalent in intended use to N/T Protein Control LC currently marketed (K991704). The modified N/T Protein Control LC, like the current N/T Protein Control LC is intended to be used as quality control material to monitor the accuracy and precision of human urine and CSF protein assays on BN™ Systems and the TurbiTimeSystem

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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 +2º to +8º C, once reconstituted.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion around the symbol. The logo is black and white.

SEP - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring Inc. P. O. Box 6101 Newark, DE 19714

Re: K032237

Trade/Device Name: N/T Protein Control LC Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: July 18, 2003 Received: July 21, 2003

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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k) Notification-Modification

Indications for Use Statement

Device Name: N/T Protein Control LC

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

A.P. Reese for T.J. O'leary
(Division Signee)

Division of Clinical Laboratory Devices

510(k) Number_1_03-2237

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.