N L.p(a) Standard SY is a lyophilized standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the olublizative determination of human lipoprotein(a) [Lp(a)] by immunochemical with BN™ Systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "N Lp(a) Standard SY," which is a calibrator for determining human lipoprotein(a) [Lp(a)] levels. The document primarily focuses on the device's classification, intended use, and substantial equivalence to a predicate device.

Unfortunately, the provided text does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, ground truth establishment, or expert involvement in a way that would allow for a comprehensive response to all the requested points.

Here's a breakdown of what can be extracted and what is missing, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability	Stable for at least 24 months at +2° to +8° C, as originally packaged.
	Stable for at least 5 days at +2° to +8° C, once reconstituted.
Other performance (e.g., accuracy, precision, linearity)	Not provided in the document.

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text. The document refers to "Dade Behring protocols" for stability evaluation but does not detail the data source (country, retrospective/prospective).

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

This device is a calibrator, not an imaging or diagnostic algorithm that relies on expert interpretation of results for ground truth. Therefore, the concept of "experts establishing ground truth" in the traditional sense for a test set is not directly applicable here. The ground truth for a calibrator would be its own certified value against a reference measurement. The document does not describe how this was established.

4. Adjudication Method for the Test Set

Not applicable as the document does not describe a study involving adjudication of a test set by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a calibrator for an in vitro diagnostic test, not an AI or imaging device designed to assist human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this product.

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

Not applicable. This device is a biochemical calibrator, not an algorithm.

7. The Type of Ground Truth Used

For a calibrator, the "ground truth" would be the assigned value of the calibrator itself, derived from a highly accurate reference method or standard. The document states it is "prepared from human serum." It's implied that the concentrations of Lp(a) in the calibrator are precisely known, but how this "truth" (i.e., the certified concentration values) was established is not detailed in the provided text. It mentions "immunochemical determination... with BN™ Systems" for its intended use, but not for the establishment of its own truth.

8. The Sample Size for the Training Set

Not applicable / Not specified. As a calibrator, it doesn't typically involve a "training set" in the context of machine learning or complex algorithms. Product development might involve studies to optimize its formulation and stability, but these are not framed as "training sets."

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

Not applicable / Not specified. (See point 8).

Summary of Missing Information:

The provided 510(k) summary focuses on regulatory aspects like device classification, intended use, and substantial equivalence. It provides minimal technical details about the performance studies beyond a high-level statement about stability testing conducted "according to Dade Behring protocols." It lacks the detailed scientific study information (e.g., specific study designs, raw data, statistical analyses, participant characteristics, and ground truth methodologies) that would be needed to fully answer your request. This level of detail is often present in supporting documentation submitted to the FDA but is usually summarized or omitted in the public-facing 510(k) summary.

Summary

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NOV 0 9 2001

510(k) Summary For N Lp(a) Standard SY

K 013126

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: Rebecca S. Ayash Tel: 302-631-6276

Preparation date:

September 14, 2001

Class II (862.1150)

Device Name/ Classification: 2.

N Lp(a) Standard SY:

Calibrator

Classification Number:

Identification of the Legally Marketed Device:

Beckman Coulter Lipoprotein(a) Calibrator (LPA CAL), K000121

Device Description: 4.

Device Intended Use: 5.

Establishment of reference curves for the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.

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

There are a number of in vitro diagnostic products that are used for the establishment of reference curves. One such product is the Beckman Coulter Lipoprotein(a) Calibrator (LPA CAL), K000121. N Lp(a) Standard SY, like the LPA CAL is intended to be used for the calibration of Lp(a) protein by rate nephelometry.

Device Performance Characteristics: 7.

Stability:

Stability was evaluated according to Dade Behring protocols and the standard was found to be stable for at least 24 months at +2° to +8° C, as originally packaged and for at least 5 days at +2° to +8° C, once reconstituted.

Image /page/0/Picture/26 description: The image shows the number 00020 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are slightly distorted, as if they were printed on a rough surface.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 0 9 2001

Ms. Rebecca S. Ayash Director, Regulatory Affairs Dade Behring Inc. P.O. Box 6101 Newark, DE 19714

Re: K013126 Trade/Device Name: N Lp(a) standard SY Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIS Dated: September 14, 2001 Received: September 19, 2001

Dear Ms. Ayash:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) prematket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The FDA inding of succementary of career and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and 1 If you desire specific advice for your actives), please contact the Office of Compliance at additionally 807.10 for in viue diagliestions on the promotion and advertising of your device, (301) 594-4508. Addinonally, 10. quee at (301) 594-4639. Also, please note the regulation prease contact the Office or Companise to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsionales and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers international and Colless "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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NOV 0 9 2001

Indications for Use Statement

K013/26

N Lp(a) Standard SY Device Name:

Indications for Use:

Establishment of reference curves for the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.

R. Charles for Jean Cooper

vision of Clinical Laboratory Devices 510(k) Number

(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)

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.