(28 days)
K0051
Not Found
No
The summary describes a chemistry assay and automated laboratory system for measuring HDL cholesterol. There is no mention of AI or ML in the intended use, device description, or other sections.
No
This device is for in vitro quantitative measurement and diagnostic purposes, not for treating any condition.
Yes
The device is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma, which is a diagnostic measurement.
No
The device description clearly states it includes reagent packs, calibrator kits, and a chemistry system with laboratory automation, all of which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma. This is a key characteristic of an IVD.
- Device Description: The "Device Description" describes the components used to perform the assay, including reagent packs, calibrators, and the chemistry system. These are all components typically used in an in vitro diagnostic test.
- Predicate Device: The mention of a "Predicate Device" with a K number (K0051) and the name "VITROS Chemistry Products dHDL Reagent Pack" strongly indicates that this device is being compared to a previously cleared IVD. This is a common practice in the regulatory process for IVDs.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma.
The VITROS 5,1 FS Chemistry System with enGen™ Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
Product codes (comma separated list FDA assigned to the subject device)
LBR, JIT, JJE
Device Description
The modified device is the VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 which are combined by the VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System to perform the VITROS dHDL assay for HDL cholesterol. The VITROS HDL assay has not been changed.
The VITROS 5.1 FS Chemistry System (instrumentation, which provides automated use of chemistry reagents) is interfaced to a Laboratory Automation System, which conducts pre-analytical and post-analytical sample and data management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Not Found
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.
K0051
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.
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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).
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§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K063144.
| Submitter | Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive MC00881
Rochester, New York 14626-5101 | NOV 13 2006 |
| ----------- | ------------------------------------------------------------------------------------------------------ | ------------- |
|---|
Sarah Parsons Contact Person: Phone: (585) 453-3154 FAX: (585) 453-3368 Email: sparson1@ocdus.jnj.com
October 13, 2006 Preparation date
Trade or Proprietary Name:
VITROS Chemistry Products dHDL Reagent Pack VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1 VITROS® 5,1 FS Chemistry System / enGen™ Laboratory Automation System
- HDL Cholesterol assay Common Name: Clinical Chemistry Analyzer / Laboratory Automation System
- Classification Name: Lipoprotein test system: 21 CFR 862.1475 Calibrator: 21 CFR 862.1150 Discrete photometric chemistry analyzer for clinical use: 21 CFR 862.2160
Device Intended Use: The VITROS Chemistry Products dHDL assay is intended for the in vitro quantitative measurement of HDL cholesterol in human serum or plasma.
The VITROS 5,1 FS Chemistry System with enGen™ Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
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- The modified device is the VITROS Chemistry Products dHDL Device description: Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 which are combined by the VITROS 5,1 FS Chemistry System with enGen Laboratory Automation System to perform the VITROS dHDL assay for HDL cholesterol. The VITROS HDL assay has not been changed.
The VITROS 5.1 FS Chemistry System (instrumentation, which provides automated use of chemistry reagents) is interfaced to a Laboratory Automation System, which conducts pre-analytical and post-analytical sample and data management.
The modified device has the same intended use, Substantial Equivalence fundamental scientific technology and operating principle as the predicate device. The VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System with enGen™ Laboratory Automation System is substantially equivalent to the VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is rendered in black and white. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sarah Parsons Manager, Regulatory Affairs Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
NOV 1 3 2006
K063144 Re:
K0051 Trade/Device Name: VITROS Chemistry Products dHDL Reagent Pack Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBR, JIT, JJE Dated: October 13, 2006 Received: October 16, 2006
Dear Ms. Parsons:
We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave reveal 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 for associated in the encreases)77 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, de neces that have been room require approval of a premarket approval application (PMA). and Oosmetic Prove, market the device, subject to the general controls provisions of the Act. The r ou may , most 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 it may be subject to bach adde of Federal Regulations (CFR), Parts 800 to 895. 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 or any I oderal bathe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Albert Gutt
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use: Instrument with Automation and Assay.
510(k) Number (if known): K063144 VITROS 5,1 FS Chemistry System with enGen™ Laboratory Device Name: Automation System VITROS Chemistry Products dHDL Reagent Pack VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1 The VITROS 5,1 FS Chemistry System with enGen™ Indications for Use: Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)
The VITROS Chemistry Products dHDL Reagent Pack, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1 are used for the quantitative measurement of HDL cholesterol in serum or plasma.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division
Office & In Viro Diagnostic Device Evaluation and Safety
510(K) X63144