N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, IgG7, IgA, IgM, C3c, C4, Transferrin, in Innonophobionou y ma2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Albumin, c.y antill Jpon) @2 maor J.g/L-chain lambda & kappa, β2-microglobulin, soluble Transferrin Receptor (STFR), Ferritin, IgE, and Total protein; and by immunoturbidimetry with the TurbiTimeSystem: IgG, IgA, IgM, C3c, C4, Transferrin, Albumin, Haptoglobin, α4acid glycoprotein.

Device Description

N/T Protein Control SL is a liquid control prepared from human serum with sfabilizers and preservative. It is intended to be used as an accuracy and precision control for the presentation of human serum proteins by immunonephelometry with BN™ Systems and by immunoturbidimetry with the TurbiTimeSystem.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the N/T Protein Control SL device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability (unopened)	At least 14 days at +2° to +8° C, as originally packaged
Stability (opened)	At least 14 days at +2° to +8° C, once opened

Note: The document primarily focuses on stability as the performance characteristic. It doesn't explicitly state quantitative acceptance limits for accuracy or precision, but rather implies they are met based on the "substantially equivalent" claim to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size used for the test set. It mentions "Dade Behring protocols" for stability evaluation but gives no details about the number of samples or runs.

The data provenance is not specified in terms of country of origin. The study appears to be prospective in nature, as it describes evaluations performed to support the 510(k) submission for this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The device is a quality control material and its performance evaluation for stability would not typically involve expert ground truth in the same way a diagnostic imaging device would. The "ground truth" here would be the measured analyte concentrations and their stability over time, determined by the instrument itself.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for this type of device and study. Adjudication methods are typically used to resolve discrepancies in expert interpretations (e.g., in clinical trials or diagnostic studies), which is not relevant for evaluating the stability of a control material.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The N/T Protein Control SL is a quality control material, not a diagnostic device requiring human reader interpretation or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study was not applicable/not done in the context of an algorithm. This device is a chemical control material for laboratory instruments, not an AI algorithm. Its "performance" refers to its chemical and physical stability and its ability to produce consistent results on specified analytical systems.

7. The Type of Ground Truth Used

For this device (a quality control material), the "ground truth" for the performance evaluation (stability) is established through instrument measurements of known analyte concentrations at different time points and under different conditions. The "accuracy" and "precision" mentioned in the intended use refer to the device's ability to verify the accuracy and precision of an analytical system using its known analyte values. The stability study aims to ensure these known values remain constant over time.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This device is a control material, not an algorithm that requires training data.

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

Since there is no "training set" for this device, this question is not applicable.

Summary

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SEP = 4 2001

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

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

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash Tel: 302-631-6276

Preparation date:

July 31, 2001

Device Name/ Classification: 2.

N/T Protein Control SL:

Quality Control Material (assayed)

Classification Number:

Class I (862.1660)

Identification of the Legally Marketed Device: 3.

N/T Protein Control SL (K002852)

Device Description: 4.

5. Device Intended Use:

Image /page/0/Picture/22 description: The image shows the word "CONFIDENTIAL" in large, bold, black letters. The letters are closely spaced and fill most of the frame. The background is plain white, providing a stark contrast to the bold text.

000027

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

The modified N/T Protein Control SL is substantially equivalent in intended use to N/T The modified NYT T Totell Control SE to Sassianaly Se Sales N/T Control SL, like the Protein Control OL (K002002) ourrolly marketsused as quality control material to current NYT Frotein Oontrol OE is interface to be accuracy in BN™ Systems and the TurbiTimeSystem.

Device Performance Characteristics: 7.

Stability:

Stability.
Stability was evaluated according to Dade Behring protocols and the control was found to Stablity was evaluation as overling to D to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once opened.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP = 4 2001

Ms. Rebecca S. Ayash Director, Regulatory Affairs Dade Behring, Inc. Glasgow Site, PO Box 6101 Newark, DE 19714

K012468 Re:

Trade/Device Name: N/T Protein Control SL Regulation Number: 21 CFR 862.1660 Regulatory Class: I, reserved Product Code: JJY Dated: July 31, 2001 Received: August 2, 2001

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 to 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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Page 2 -

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 v 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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.
N/T Protein Control SL
510(k) Notification

Indications for Use Statement

N/T Protein Control SL Device Name:

Indications for Use:

N/T Protein Controls SL/L, M, and H are for use as accuracy and precision N/ 1 Toteln Controls of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, IgG14, IgA, IgM, C3c, C4, immanonopholomosiy wantitrypsin, α2-macroglobulin, Haptoglobin, α;-acid Translermir, Albumin, or antilippensin, Ceruloplasmin, RbP, Ig/L-chain lambda & giyooprotein, 1 Toalbumin, Huble Transferrin Receptor (STTR), Ferritin, IgE, and Kappa, p2-morogiobailin, obluble idimetry with the TurbiTimeSystem: IgG, IgA, IgM, C3c, C4, Transferrin, Albumin, Haptoglobin, α+-acid glycoprotein.

(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)

Kesia Alexander for Liam Cooper
(Division Sign-Off)

510(k) Number

000025

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.