(149 days)
Not Found
No
The device description details a standard immunoassay technique and does not mention any AI or ML components in its operation or data analysis.
No
The device is an in vitro diagnostic test for measuring Lp(a) levels and is used in evaluating lipid metabolism disorders and atherosclerotic cardiovascular disease, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test" used for evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease, which are diagnostic purposes.
No
The device is an in vitro diagnostic assay kit, which is a physical product containing reagents and intended for use with a specific analyzer (Hitachi 917). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test" for the quantitative determination of Lp(a) in human serum and plasma samples.
- Device Description: It describes a "latex in vitro diagnostic immunoassay" that analyzes biological samples (serum and plasma) outside of the body to provide diagnostic information.
- Predicate Device: The mention of a predicate device (K982708; SPQ Test System Antibody Reagent Set for Lp(a) [DiaSorin Inc.]) which is also an IVD, further confirms its classification.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
Product codes
DFC
Device Description
The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of Lipoprotein (a) in human serum and plasma. Antigen in the sample binds to the specific anti-Lp(a) antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on Hitachi 917 analyzer, with the magnitude of the change being proportional to the quantity of Lp(a) in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentrations.
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)
Comparative performance studies, when conducted on 105 donor samples, yielded a correlation coefficient upon comparison of the Lp(a)-Latex SEIKEN and the SPQ Test System Antibody Reagent Set for Lp(a) of r = 0.919.
Precision studies were performed using medium and high control materials. % CV for the medium control was 2.00%; for the high control, the % CV was 1.26.
The lower level of detection (sensitivity of the assay) is at 2.0 mg/dL, with the assay range up to 80.0 mg/dL.
These findings demonstrate that the performance of the Lp(a)-Latex SEIKEN Assay kit is both robust and substantially equivalent to the predicate device, SPQ Test System Antibody Reagent Set for Lp(a).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The lower level of detection (sensitivity of the assay) is at 2.0 mg/dL, with the assay range up to 80.0 mg/dL.
Precision studies: % CV for the medium control was 2.00%; for the high control, the % CV was 1.26.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).
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8 2002 MAR
MAR
I. 510(k) Summary
The assigned 510 (k) number is:
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1013359
Denka Seiken Co., Ltd. (A)(1) Submitter's name:
Submitter's address: 3-4-2. Nihonbashi kavabacho
Chuo-ku Tokyo, Japan 103-0025
Submitter's telephone number: (03) 3669-9421
Contact Person: Mr. Yousuke Meguro Assistant Manager International Sales and Business Development Dept.
Date Summary Prepared: February 1, 2002
(2) Trade or proprietary device name:
- (3) Common or usual name: Classification Name: Panel: Immunology Class: II
Lp(a)-Latex SEIKEN Assay Lipoprotein (a) assay Low density Lipoprotein Immunological test system
(3) Legally marketed predicate device(s): SPQ Test System Antibody Reagent Set for Lp(a) DiaSorin Inc.
(4) Subject device description:
The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of Lipoprotein (a) in human serum and plasma. Antigen in the sample binds to the specific anti-Lp(a) antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on Hitachi 917 analyzer, with the magnitude of the change being proportional to the quantity of Lp(a) in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentrations.
1
(5) Subject device intended use:
The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
(6) Performance data:
The Lp(a)-Latex SEIKEN Assay and the predicate device, SPQ Test System Antibody Reagent Set for Lp(a) methods and reagents have only minor difference that do not affect the performance, safety or effectiveness of the measurement.
Comparative performance studies, when conducted on 105 donor samples, yielded a correlation coefficient upon comparison of the Lp(a)-Latex SEIKEN and the SPQ Test System Antibody Reagent Set for Lp(a) of r = 0.919.
Precision studies were performed using medium and high control materials. % CV for the medium control was 2.00%; for the high control, the % CV was 1.26.
The lower level of detection (sensitivity of the assay) is at 2.0 mg/dL, with the assay range up to 80.0 mg/dL.
These findings demonstrate that the performance of the Lp(a)-Latex SEIKEN Assay kit is both robust and substantially equivalent to the predicate device, SPQ Test System Antibody Reagent Set for Lp(a).
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Yousuke Meguro Assistant Manager International Sales and Business Development Department Denka Seiken Co., Ltd. 3-4-2, NIHONBASHI-KAYABACHO CHUO-KU, TOKYO JAPAN 103-0025
MAR 8 2002
K013359 Re:
Trade/Device Name: Lp(a)-Latex SEIKEN Assay Kit Regulation Number: 21 CFR 866.5600 Regulation Name: Low density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: February 1, 2002 Received: February 4, 2002
Dear Mr. Meguro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimered prices that have been reclassified in accordance with the provisions of the Federal Food, DNLS 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 Tou may, dicrorely, mans 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 If your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a success 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 i lease of actived that i Drivistion that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must or mry 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 CI It Fat 607); adoning (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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Page 2 -
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 1 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/cdrb/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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Amendments to Denka Seiken Co., Ltd. Pre-market Notification Lp(a)-Latex SEIKEN Assay Kit
C. Indications for use of the Device Page 1 of 1
| 510(k) Number): | K013359 |
|---|---|
| Device Name: | Lp(a)-Latex SEIKEN Assay Kit |
Indications for Use:
The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determina-
tion of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer.
The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing ath-
erosclerotic cardiovascular disease in specific populations, when used in conjunction with clini-
cal evaluation and other lipoprotein tests.(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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signature
vices
Prescription Use_X _or (Per 21 CFR 801.109) (Optional Format 1-2-96)
Over-the-Counter Use