(29 days)
Not Found
No
The summary describes a laboratory control material for a diagnostic test, not a device that processes data or images using AI/ML.
No
The device is described as an "assayed control for accurancy and precision of the immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma." It is intended for quality control in laboratory testing, not for treating or diagnosing patients.
No.
This device is described as an "assayed control" and a "lyophilized control" intended for "accuracy and precision of the immunochemical determination of human lipoprotein(a)". It is used to verify the performance of other diagnostic devices (BN™ Systems) that measure Lp(a), rather than directly diagnosing a condition in a patient.
No
The device description explicitly states it is a lyophilized control prepared from human serum, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "immunochemical determination of human lipoprotein(a) [Lp(a)] in serum or plasma". This involves testing biological samples (serum or plasma) outside of the body to obtain information about a patient's health status (specifically, their Lp(a) levels).
- Device Description: The description confirms it is a "lyophilized control prepared from human serum" and 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." This further reinforces its role in an in vitro diagnostic testing process.
- Predicate Device: The mention of a predicate device (Macra Lp(a) Control, K992665) which is also an IVD control, strongly suggests that this device falls under the same regulatory category.
The core function of this device is to serve as a control for a diagnostic test performed on biological samples in vitro (outside the living organism). This is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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:
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.
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
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
Image /page/4/Picture/13 description: The image contains the word "CONFIDENTIAL" in large, bold, black letters. The letters are slightly slanted, giving the word a dynamic appearance. The font is simple and sans-serif, making the word easily readable.
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