(19 days)
Not Found
No
The device description details a chemical assay based on enzymatic reactions and absorbance measurements, with no mention of AI or ML technologies.
No.
The device is described as an "in vitro diagnostic reagent system" used for quantitative determination of HDL-cholesterol for diagnosis and treatment of lipid disorders, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states that "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This indicates its role in diagnosis.
No
The device description clearly outlines a reagent system and a test principle involving chemical reactions and absorbance measurements, indicating a hardware component (the COBAS Integra system) is required for its function. It is an in vitro diagnostic reagent, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The cassette COBAS Integra HDL-Cholesterol plus 2nd Generation contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma." This directly identifies it as an in vitro diagnostic device.
- Purpose: The intended use describes measuring a substance (HDL-cholesterol) in a biological sample (serum and plasma) to aid in the diagnosis and treatment of various medical conditions (lipid disorders, atherosclerosis, liver and renal diseases). This is a core function of IVD devices.
- Device Description: The description details a chemical reaction and measurement process performed on a sample outside the body, which is characteristic of in vitro diagnostics.
The presence of the phrase "in vitro diagnostic reagent system" in the intended use is the most definitive indicator.
N/A
Intended Use / Indications for Use
The cassette COBAS Integra HDL-Cholesterol plus 2nd Generation contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Product codes (comma separated list FDA assigned to the subject device)
LBS
Device Description
The HDL-Cholesterol plus 2nd Generation test principle uses magnesium sulfate and dextran sulfate to form water-soluble complexes with LDL, VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The cholesterol concentration of HDL-cholesterol is determined enzymatically by cholesterol esterase and cholesterol oxidase coupled with PEG. The color intensity of the blue quinoneimine dye formed is directly proportional to the HDL-cholesterol concentration. It is determined by measuring the increase in absorbance at 583 nm.
Mentions image processing
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
AUG - 8 2001
| 510(k) Summary | K012286 |
|---|---|
| Introduction | According to the requirements established in the Food and Drug |
| Administration's guidance document entitled "The New 510(k) Paradigm: | |
| Alternate Approaches to Demonstrating Substantial Equivalence in Premarket | |
| Notifications", the following information provides sufficient detail to | |
| understand the basis for a determination of substantial equivalence. | |
| Submitter | |
| name, address, | |
| contact | Roche Diagnostics Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 521 - 3831 |
Contact Person: Sherri L. Coenen
Date Prepared: July 17, 2001 |
| Device Name | Proprietary name: HDL-Cholesterol plus 2nd Generation |
| | Common name: HDL-Cholesterol |
| | Classification name: Lipoprotein test system |
| Predicate
Device | We claim substantial equivalence to the currently marketed Roche/Hitachi
HDL-Cholesterol plus 2nd generation assay (K963213). |
| Device
Description | The HDL-Cholesterol plus 2nd Generation test principle uses magnesium
sulfate and dextran sulfate to form water-soluble complexes with LDL,
VLDL, and chylomicrons which are resistant to PEG-modified enzymes. The
cholesterol concentration of HDL-cholesterol is determined enzymatically by
cholesterol esterase and cholesterol oxidase coupled with PEG. The color
intensity of the blue quinoneimine dye formed is directly proportional to the
HDL-cholesterol concentration. It is determined by measuring the increase in
absorbance at 583 nm. |
| Intended use | The cassette COBAS Integra HDL-Cholesterol plus 2nd Generation contains
an in vitro diagnostic reagent system intended for use on COBAS Integra
systems for the quantitative determination of HDL-cholesterol concentration
in serum and plasma. |
| Indications for Use | A lipoprotein test system is a device intended to measure lipoprotein in serum
and plasma. Lipoprotein measurements are used in the diagnosis and
treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and
various liver and renal diseases. |
| Substantial Equivalence | The proposed device is the HDL-Cholesterol plus 2nd generation reagent
packaged for and applied to the COBAS Integra family of analyzers. The
COBAS Integra family application described in this submission is, in our
opinion, substantially equivalent to the predicate device. |
| Comparison to
predicate
device | The COBAS Integra application of the HDL-cholesterol plus 2nd generation
assays has the same intended use and indication for use, the same scientific
principle, the same formulation and similar application parameters as the
predicate device, the HDL-Cholesterol plus 2nd generation assay as applied
to the Roche/Hitachi family of analyzers. |
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510(k) Summary, Continued
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract representation of a bird or a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 8 2001
Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
510(k) Number: K012286 Re: Trade/Device Name: HDL-Cholesterol plus 2nd Generation Regulation Number: 862.1475 Regulatory Class: I, reserved Product Code: LBS Dated: July 17, 2001 Received: July 20, 2001
Dear Ms. Coenen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
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 notification. The FDA inding of successification 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 If you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 809.10 for in this daglestions on the promotion and advertising of your device, (301) 394-4588. Additionally, for quest to on a processed on a more and the regulation
please contact the Office of Compliance at (301) 594-4639. Also, please of Complete please contact the Office of Comphanol at (201) of the stimation" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsioniass are unber (800) 638-2041 or (301) 443-6597 or at its Manufacturers 71851502139999 w.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Stoven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: HDL-Cholesterol plus 2nd Generation
Indications For Use:
The cassette COBAS Integra HDL-Cholesterol plus 2nd Generation (HDL-C) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid prasma. Libertes mellitus), atherosclerosis, and various liver and renal diseases.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Kesia Alexander Sr. Juan Capr