(28 days)
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.) 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.
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.
The provided text is a 510(k) summary for a medical device and does not contain the detailed study information required to answer all parts of your request. This document is a regulatory submission, not a scientific study report.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. A 510(k) often asserts substantial equivalence to a predicate device rather than providing extensive performance data against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 510(k) summary.
5. 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
A multi-reader multi-case (MRMC) study is typically performed for imaging devices where human interpretation is involved. This device is a clinical chemistry system (in vitro diagnostic device) for measuring HDL cholesterol. Therefore, an MRMC study is not applicable and was not performed. The device is an automated system, not one that assists human readers in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an automated clinical chemistry system. Its performance is inherently "standalone" in the sense that it performs quantitative measurements without human intervention in the measurement process itself, beyond loading samples and reagents. The 510(k) claims substantial equivalence for the "VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System with enGen™ Laboratory Automation System" to "the VITROS dHDL assay performed on the VITROS® 5,1 FS Chemistry System." This implies performance was assessed for the automated system. However, specific details of this assessment are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quantitative clinical chemistry assay, the "ground truth" would typically be established by a reference method or a highly accurate laboratory method for measuring HDL cholesterol. However, the specific method used as ground truth for the equivalence study is not mentioned in this summary.
8. The sample size for the training set
This information is not present in the provided 510(k) summary. This document is for a traditional IVD device, not an AI/ML medical device as commonly understood for "training sets." The device is a reagent pack and calibrators used with a chemistry system.
9. How the ground truth for the training set was established
Not applicable as this is an IVD device, not an AI/ML medical device with "training sets" in the conventional sense.
Summary of what is available from the text:
- Device: VITROS Chemistry Products dHDL Reagent Pack, Calibrator Kit 19, FS Calibrator 1, used with VITROS 5,1 FS Chemistry System and enGen Laboratory Automation System.
- Intended Use: In vitro quantitative measurement of HDL cholesterol in human serum or plasma.
- Study described (implicitly): A substantial equivalence study comparing the modified system (with enGen Automation) to the predicate system (without enGen Automation) for the dHDL assay.
- Claim of equivalence: The modified device has the same intended use, fundamental scientific technology, and operating principle as the predicate device. The dHDL assay performed on the modified system is substantially equivalent to the dHDL assay performed on the predicate system. This suggests that the study aimed to show performance comparability rather than meeting specific performance criteria against a clinical gold standard.
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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 MC00881Rochester, 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
§ 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.