The N Lp(a) Control SY is an assayed control for accurancy and precision of the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.

Device Description

N Lp(a) Control SY is a lyophilized control prepared from human serum with stabilizers and preservative. It is intended to be used as an accuracy and precision control for the determination of human lipoprotein(a) [Lp(a)] by immunochemical with BN™ Systems.

AI/ML Overview

The provided text describes a medical device, the N Lp(a) Control SY, which is a quality control material. The performance characteristics section primarily focuses on stability rather than analytical performance metrics like sensitivity, specificity, or accuracy compared to a ground truth for a diagnostic device.

Therefore, the requested information elements (especially those pertaining to AI/algorithm performance, ground truth, expert adjudication, multi-reader studies, and sample sizes for test/training sets) are not applicable or cannot be extracted from this document, as it describes a control material, not a diagnostic algorithm.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance for N Lp(a) Control SY (Stability)

Acceptance Criteria	Reported Device Performance
Stability for packaged product at +2° to +8° C	Stable for at least 24 months
Stability for reconstituted product at +2° to +8° C	Stable for at least 5 days

Missing or Not Applicable Information (due to device type):

Sample size used for the test set and the data provenance: Not applicable. This device is a control material, not a diagnostic device relying on a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for a control material's stability.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Ground truth adjudication for diagnostic performance is not relevant for a control material's stability.
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 device is a control material, not an AI-powered diagnostic tool requiring human-in-the-loop studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a control material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a control material relates to its assigned value and stability over time, which is determined by analytical methods and manufacturing specifications, not patient outcomes or expert consensus on clinical data.
The sample size for the training set: Not applicable. This device is a control material, not an algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable. This device is a control material, not an algorithm that requires a training set.

Summary

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OCT 1 8 2001

KO13130 510(k) Summary For N Lp(a) Control SY

Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. 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: Rebecca S. Ayash Tel: 302-631-6276

Preparation date:

September 14, 2001

Device Name/ Classification: 2.

N Lp(a) Control SY:

Quality Control Material (assayed)

Classification Number:

Class I (862.1660)

ldentification of the Legally Marketed Device: 3.

Macra Lp(a) Control (K992665)

4. Device Description:

5. Device Intended Use:

The N Lp(a) Control SY is an assayed control for accuracy and precision of 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 as accuracy and precision controls for the determination of human lipoprotein(a) [Lp(a)]. One such product is the Macra Lp(a) Control, K992665. N Lp(a) Control SY, like the Macra Lp(a) Control, is intended to be used as quality control material to monitor the accuracy and precision of Lp(a) assays .
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7. Device Performance Characteristics:

Stability:

Stability was evaluated according to Dade Behring 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 5 days at +2° to +8° C, once reconstituted.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 8 2001

Ms. Kathleen Dray-Lyons Regulatory Affairs Specialist Dade Behring, Inc. Glasgow Site PO Box 6101 Newark, DE 19714

Re: K013130

Trade/Device Name: N Lp(a) Control SY Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality Control Material (Assayed and Unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: September 14, 2001 Received: September 19, 2001

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 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) 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 Butman

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 Lp(a) Control SY 510(k) Notification

Indications for Use Statement

K013130

Device Name:

N Lp(a) Control SY

Indications for Use:

The N Lp(a) Control SY is an assayed control for accurancy and precision of the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma with BN™ Systems.

(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-Jordan Cooper
Division Sign Off

oratory Devices Clinical 510(k) Number

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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.