N Apolipoprotein Standard Serum is a lyophilized calibrator prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of Apolipoprotein A-I and Apolipoprotein B assays on BNTM Systems.

AI/ML Overview

This document describes the N Apolipoprotein Standard Serum, a lyophilized calibrator for Apolipoprotein A-I and Apolipoprotein B assays. The primary study presented focuses on the stability of the device, rather than a clinical performance study with human readers or standalone algorithm performance.

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1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability (Shelf Life)	No significant change in recovery for at least 36 months, stored at 2° to 8° C.
Stability (Reconstituted)	No significant change in recovery for 15 days, once reconstituted.

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

Sample Size: Three lots of N Apolipoprotein Standard Serum were used for the stability testing.
Data Provenance: Not explicitly stated, but given it's a calibrator manufactured by Dade Behring Marburg GmbH and its intended use is for BN™ Systems, the testing would generally occur in a laboratory setting by the manufacturer. The data is retrospective in the sense that stability is assessed over time after manufacturing.

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

Not applicable. The study is a stability test for a calibrator, not a study evaluating diagnostic accuracy against a clinical ground truth established by experts. The "ground truth" here is the expected stable performance of the calibrator over time, measured by quantitative recovery.

4. Adjudication Method for the Test Set

Not applicable. This was a direct measurement of quantitative recovery over time, not a qualitative assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a calibrator, not an AI-powered diagnostic tool. Therefore, there's no human reader involvement or AI assistance to measure improvement against.

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

No, a standalone algorithm performance study was not done. This device is a physical calibrator, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this study is the expected quantitative recovery of Apolipoprotein A-I and Apolipoprotein B values over time under specified storage and use conditions. It's an internal quality control standard based on the known composition and intended function of the calibrator.

8. The Sample Size for the Training Set

Not applicable. This device is a calibrator for existing assays and does not involve AI or machine learning models that require a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for one.

Summary

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510(k) Summary N Apolipoprotein Standard Serum

Manufacturer'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: Donna Wolf Tel: 302-631-0384 July 8, 2004

KO41870

Preparation date:

Device Name/ Classification:

N Apolipoprotein Standard Serum / Calibrator, Class II (862.1150)

3. Identification of the Legally Marketed Device:

Randox Apolipoprotein Calibrator (K023158)

4. Device Description:

5. Device Intended Use:

For calibration of the Apolipoprotein A-I and Apolipoprotein B assays on BN™ Systems.

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

There are a number of in vitro diagnostic products that are used for the establishment of reference curves. One such product is the Randox Laboratories Apolipoprotein Calibrator (K023158). Both products are lyophilized humanbased calibrators intended for the calibration of Apolipoprotein A-1 and B.

7. Device Performance Characteristics:

Stability:

Stability was evaluated by testing N Apolipoprotein Standard Serum in duplicate at each time point for a total of three lots. The standard was evaluated at the recommended storage temperature of 2° to 8° C. Stability testing supports no significant change in recovery for at least 36 months, and for 15 days, once reconstituted.

The N Apolipoprotein Standard Serum is substantially equivalent to other comparable calibrator products in commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

JUL 27 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Donna Wolf Regulatory Affairs and Compliance Manger Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

K041870 Re:

Trade/Device Name: N Apolipoprotein Standard Serum Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 8, 2004 Received: July 13, 2004

Dear Ms. Wolf:

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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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,

Jean M. Cooper, MS, DVM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:___ N Apolipoprotein Standard Serum

Indications For Use:

For calibration of the Apolipoprotein A-I and Apolipoprotein B assays on BN™ Systems.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto Sating
Division Sign-Off

Dev

510(k) K041870

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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.