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 the Behring Nephelometer Systems: IgG, IgGirl IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, α2-macroglobulin, Haptoglobin, a - acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, β>-microglobulin, Soluble transferrin receptor (sTfR), Ferritin, lgE; and, by immunoturbidmetry with the TurbiTimeSystem: (gG, IgGj1, IggA, controls con also be has be haptoglobin, a ;- acid glycoprotein, The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.

Device Description

N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and preservative: 16 minin serum proteins by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

AI/ML Overview

The provided document describes the N/T Protein Control SL, a liquid control prepared from human serum for use as an accuracy and precision control for human serum proteins. The only performance characteristic mentioned and evaluated in this document is Stability.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability	At least 12 months at +2° to +8° C (unopened)
Stability	At least 14 days at +2° to +8° C (once opened)

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

The document states: "Stability was evaluated according to in-house protocols".

Sample Size: Not explicitly stated.
Data Provenance: The study was conducted in-house by Dade Behring. It is a retrospective evaluation of the control's stability under specified conditions. The country of origin of the data is Germany (Dade Behring Marburg GmbH) and/or USA (Dade Behring Inc.).

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

Number of Experts: Not applicable. The "ground truth" for stability testing of a control material typically involves analytical measurements and comparison to defined specifications, not expert consensus in the traditional sense.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of images or clinical cases to establish ground truth, which is not relevant for this type of chemical stability testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is a quality control material for laboratory assays, not a diagnostic imaging device that would typically involve human readers.

6. Standalone Performance Study

Standalone Study Done: Yes. The stability evaluation is inherently a standalone assessment of the control material's performance over time, independent of human intervention beyond the initial testing and storage conditions.

7. Type of Ground Truth Used

Type of Ground Truth: Analytical measurements (e.g., immunonephelometry, immunoturbidimetry) against predefined specifications for the various proteins, monitored over time. The "ground truth" for stability is maintaining the established concentration/activity levels within acceptable limits over the specified period.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is a quality control material intended for use in an assay, not an algorithm that requires a training set in the machine learning sense. The "development" of the control material would involve formulation refinement and extensive analytical testing, but not a "training set" as understood in AI/ML.

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

Ground Truth for Training Set: Not applicable, as there is no training set in the AI/ML context. The formulation and initial characterization of the control material (its 'ground truth' values for protein concentrations) would be established through a rigorous process of assaying the prepared material against traceable reference materials or highly characterized methods.

Summary

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MAY 19 1999

Dade Behring Inc.
N/T Protein Control SL
510(k) Notification

Image /page/0/Picture/1 description: The image shows a black and white picture with some dark shapes on the left side and the text "K991182" on the right side. The shapes on the left are abstract and do not have a clear form. The text is handwritten in a cursive style. The text appears to be a code or identification number.

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

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

Manufacturer:

Contact Information:

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

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Carolyn K. George Tel: 302-631-6283

Preparation date:

April 5, 1999

Device Name/ Classification: 2.

N/T Protein Control SL:

Classification Number:

Class I (862.1660)

Quality Control Material (assayed)

Identification of the Legally Marketed Device: 3.

N/T Protein Control SL (K964065)

Device Description: 4.

N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and Nr 1 rotein Oontrol October of a liquia contracy and precision control for the preservative: 16 minin serum proteins by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.

Device Intended Use: ક.

N/T Protein Controls SLIL, M, and H are for use as accuracy and precision controls in the 14/11 Toteln Gontrolo ODE, will han serum proteins by immunonephelometry with the delehring Nephelometer Systems: IgG, IgG+++ IgA, IgM, C3c, C4, Transferrin, Albumin, a++ antitrypsin, a2-macroglobulin, Haptoglobin, a1-acid glycoprotein, Prealbumin, antil Jpoin, αշ maorogiou & kappa, βչ-microglobulin, Soluble transferrin, Soluble transferrin, Gerdloplasmin, Nor , igre onain larks and by immunoturbidmetry with the TurbiTimeSystem: IgG, roopler (GTTT), COMAN), C3c, C4, Transferrin, Albumin, Haptoglobin, x1-acid glycoprotein, The rg of in the many be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.

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Dade Behring Inc. N/T Protein Control SL 510(k) Notification

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

The N/T Protein Control SL (modified to include sTfR) is substantially equivalent in intended use to the N/T Protein Control SL (K964065) currently marketed. The N/T Control SL (modified), like the current N/T Protein Control SL is intended to be used as quality control material to monitor the accuracy and precision of human serum protein assays on the Behring Nephelometer Systems and TurbiTimeSystem.

7. Device Performance Characteristics:

Stability:

Stability was evaluated according to in-house protocols and the control 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a partial view of a logo or emblem, featuring the text 'DEPARTMENT OF HEALTHY & H'. The text is arranged in a curved manner, suggesting it forms part of a circular design. Adjacent to the text are abstract, curved lines, possibly representing a stylized graphic element or symbol associated with the department.

MAY 1 9 1993

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carolyn K. Goorge Manager, Regulatory Affairs, Biology Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714

Re: K991182

Trade Name: N/T Protein Control SL: Quality Control Material Regulatory Class: 1 Product Code: JJY Dated: April 5, 1999 Received: April 7, 1999

Dear Ms. George :

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 latt 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 adultcration.

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 cquivalent 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 unight 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

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 procced 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 Autman

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

Device Name: N/T Protein Control SL

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 Devices
	510(k) Number F791182
Prescription Use(Per 21 CFR 801.109)	Over-The-Counter-Use(Optional Format 1-2-96)

CONFIDENTIAL

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.