(20 days)
For in vitro diagnostic use only.
The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma.
VITROS Calibrator Kit 2
For in vitro diagnostic use only.
VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.
The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (modified) and VITROS Chemistry Products Calibrator Kit 2
The provided 510(k) summary describes a Special 510(k) submission for modifications to existing devices, specifically the VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides, and VITROS Chemistry Products Calibrator Kit 2. The focus of this submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish new comprehensive performance criteria from scratch.
Therefore, the information available is primarily a comparison against the existing, cleared predicate device rather than presenting entirely new acceptance criteria and a standalone validation study that would typically be detailed for a novel device.
Here's an analysis based on the available text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" for the modified device in terms of specific performance metrics (e.g., accuracy, precision targets). Instead, the demonstration of equivalence relies on showing that the modified device performs similarly to the predicate device across relevant characteristics and through comparative studies. The table presented focuses on the differences in device characteristics between the predicate and new device, rather than performance criteria.
However, the "Conclusions" section states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies that the de facto acceptance criteria were that the performance characteristics (e.g., accuracy, precision) of the modified device, when measured with patient and QC samples across the assay range, were within acceptable limits of the predicate device's established performance, demonstrating "substantial equivalence."
| Characteristic/Study Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantial equivalence to the predicate device (K984303) in terms of safety and effectiveness for quantitative measurement of HDL-Cholesterol in serum and plasma. | Demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range. |
| Assay Range | No change from predicate device. | 3.0- 100.0 mg/dL (No Change) |
| Intended Use | No change from predicate device. | For in vitro diagnostic use only. Quantitatively measure HDL-Cholesterol (HDLC) in serum and plasma. (No Change) |
| Basic Principle | No change from predicate device. | HDL separation by precipitation, magnetic removal of non-HDL lipoproteins, dry multilayered slide utilizing reflectance spectrophotometry. (No Change) |
| Sample Type | No change from predicate device. | Serum, Plasma (No Change) |
| Instrumentation | No change from predicate device. | VITROS 250, 550, 750 and 950 Series Analyzers (No Change) |
| Incubation time & temperature | No change from predicate device. | 5 minutes at 37°C (No Change) |
| Reactive Ingredients per CHOL slide (test) | Within acceptable manufacturing variation for modified quantities, ensuring equivalent performance to predicate. | Triton X-100 0.73 mg; cholesterol oxidase 0.36 U; cholesterol ester hydrolase 1.80 U; peroxidase 4.68 U; leuco dye 0.13 mg. (Reduced quantities from predicate) |
| Sample volume | Reduced volume with equivalent performance to predicate. | 5.5 µL (Reduced from 10 uL) |
2. Sample Size Used for the Test Set and Data Provenance
The summary states: "Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range."
However, specific numerical sample sizes for the test set (number of patient samples, number of QC samples) are not reported in this 510(k) summary.
Data provenance (e.g., country of origin, retrospective/prospective) is not explicitly mentioned. Typically for IVDs, samples would be of human origin, and often from diverse populations to ensure generalizability, but this detail is absent. The study appears to be a laboratory validation study, likely prospective for the purpose of this submission if new lots were manufactured and tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is an in vitro diagnostic (IVD) device designed to quantitatively measure a biomarker (HDL-Cholesterol). The "ground truth" for such devices is established by reference methods or comparison to a legally marketed predicate device, as opposed to expert human interpretation of images or clinical assessments.
Therefore, the concept of "experts used to establish ground truth" in the way it applies to imaging AI (e.g., radiologists) is not applicable here. The ground truth would be the actual HDL-Cholesterol concentration as determined by a highly accurate or reference method, against which the device's measurements are compared. The expertise involved would be in clinical chemistry and laboratory professionals performing the reference measurements and statistical analysis.
4. Adjudication Method for the Test Set
As this is an IVD device measuring a quantitative biomarker, an "adjudication method" in the sense of reconciling disagreements between multiple human readers (as in imaging studies) is not applicable. The "adjudication" of results would involve standard laboratory quality control procedures, statistical analysis of agreement between the modified device and the predicate/reference method, and assessment against predefined analytical performance specifications. No specific method beyond general "demonstration of equivalence" is detailed in this 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
This question is not applicable as this is an in vitro diagnostic (IVD) device for quantitative measurement of HDL-Cholesterol, not an AI-based imaging diagnostic device assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not entirely applicable in the AI sense. This device is a reagent and slide system that, when used with an analyzer (VITROS 250, 550, 750, and 950 Series Analyzers), quantitatively measures HDL-Cholesterol. The "standalone" performance is the device's ability to accurately measure the analyte. The study demonstrated the performance of the modified reagent/slides with the analyzer systems, demonstrating equivalence to the predicate. There isn't a separate "human-in-the-loop" component in the direct measurement process of this type of IVD, beyond a laboratory technician operating the instrument and interpreting the numerical output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this IVD device, the "ground truth" would implicitly be the measured HDL-Cholesterol values obtained from the predicate device (K984303) or potentially a recognized reference method, as indicated by the statement: "Equivalence was demonstrated... along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range." This implies a comparison against established, presumably accurate, values.
8. The Sample Size for the Training Set
This type of device (reagents and slides for chemical measurement) does not typically involve a "training set" in the machine learning/AI sense. Its performance is based on the chemical reactions and optical measurement principles. The development and optimization of the reagent formulation might involve experimental testing, but it's not a "training set" for an algorithm. Therefore, this information is not provided.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the AI sense for this IVD device, this question is not applicable.
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Summary Information
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: 012593
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Ortho-Clinical Diagnostics, Inc. 1. Submitter name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 contact (716) 453-4041
Marlene A. Shulman Contact Person: -
Date Special 510(k) prepared: August 9, 2001 2. Preparation date
-
- Device Trade or Proprietary Name: VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent name VITROS CHOL Slide VITROS Chemistry Products Calibrator Kit 2 Common Name: HDLC Precipitating Reagent Classification Name: LDL & VLDL Precipitation, HDL
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The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and 4. Predicate VITROS CHOL Slides (modified) and VITROS Chemistry Products device Calibrator Kit 2 are substantially equivalent to the VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2.
Continued on next page
3
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510(k) Summary, Continued
- The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and 7. Comparison VITROS CHOL Slides (modified) and VITROS Chemistry Products to Predicate VITROS CHOE Shaos (instally equivalent to VITROS Chemistry Products Device Canorator Rit 2 are Sabbaniano, expent and VITROS CHOL Slides for use with Magnetic HDL-Cholesteror Reagues cleared by the FDA (K984303 January 28, 1999) for in vitro diagnostic use.
Table 1 lists the characteristics of the tests performed using the VITROS Fable I hists the entarasterol Reagent and VITROS CHOL Slide (current) and Magnetic HDL Cholesterol Reagent and VITROS CHOL Slides (modified)
| Table I List of Device Characteristics. Comparison to | |||
|---|---|---|---|
| Device | Predicate Device | New Device | |
| Characteristic | VITROS Magnetic HDL-Cholesterol | VITROS Magnetic HDL-Cholesterol | |
| Reagent and VITROS CHOL Slide | Reagent and VITROS CHOL Slide | ||
| (Current) | (Modified) | ||
| Sample volume | 10 uL | 5.5 µL | |
| Quantity of | Triton X-100 0.91 mg; cholesterol oxidase | Triton X-100 0.73 mg; cholesterol oxidase | |
| Reactive | (Nocardia or Cellulomonas, E.C.1.1.3.6) 0.45 U; | (Nocardia or Cellulomonas, E.C.1.1.3.6) 0.36 U; | |
| Ingredients per | cholesterol ester hydrolase (Candida rugosa or | cholesterol ester hydrolase (Candida rugosa or | |
| CHOL slide (test) | Pseudomonas, E.C.3.1.1.13) 2.25 U; peroxidase | Pseudomonas, E.C.3.1.1.13) 1.80 U; peroxidase | |
| (horseradish root, E.C.1.11.1.7) 5.85 U; and 2- | (horseradish root, E.C.1.11.1.7) 4.68 U; and 2- | ||
| (3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4- | (3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4- | ||
| dimethylaminophenyl) imidazole (leuco dye) 0.25 | dimethylaminophenyl) imidazole (leuco dye) 0.13 | ||
| mg. | mg. | ||
| Intended Use | For in vitro diagnostic use only. | No Change. | |
| The VITROS Magnetic HDL reagent and | |||
| VITROS Cholesterol slides quantitatively measure | |||
| HDL-cholesterol (HDLC) in serum and plasma. | |||
| Concentrations of | Triton X-100 0.81 mg; cholesterol oxidase | No Change. | |
| CHOL Reactive | (Nocardia or Cellulomonas, E.C.1.1.3.6) 0.4 U; | ||
| Ingredients per | cholesterol ester hydrolase (Candida rugosa or | ||
| cm-squared | Pseudomonas, E.C.3.1.1.13) 2.0 U; peroxidase | ||
| (horseradish root, E.C.1.11.1.7) 5.2 U; and 2-(3,5- | |||
| dimethoxy-4-hydroxyphenyl)-4,5-bis(4- | |||
| dimethylaminophenyl) imidazole (leuco dye) 0.17 | |||
| mg. | |||
| Magnetic HDL- | Dextran sulfate (50,000 MW); Magnesium | No Change. | |
| Cholesterol | Chloride, Magnetically responsive particles. | ||
| Reagent Reactive | |||
| Ingredients. |
vice Characteristics: Comparison to Predicate Device
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510(k) Summary, Continued
| DeviceCharacteristic | Predicate DeviceVITROS Magnetic HDL-CholesterolReagent and VITROS CHOL Slide(Current) | New DeviceVITROS Magnetic HDL-CholesterolReagent and VITROS CHOL Slide(Modified) |
|---|---|---|
| Basic principle | HDL is separated by precipitation of LDL andVLDL by using dextran sulfate (MW 50,000) andmagnesium chloride. The reagent also containsiron particles that are coated with a polymer. Thepolymer enhances the precipitation of the non-HDL lipoproteins onto the iron particles. Theprecipitated non-HDL lipoproteins are removedfrom the supernate by applying a magnetic field.Following pretreatment of the sample, HDLcholesterol is measured by a dry, multilayeredslide utilizing reflectance spectrophotometry | No Change. |
| Sample type | Serum , plasma | No Change. |
| Assay RangeSerum, Plasma | 3.0- 100.0 mg/dL | No Change. |
| Instrumentation | VITROS 250, 550, 750 and 950 Series Analyzers | No Change. |
| Incubation timeand temperature | 5 minutes at 37°C | No Change. |
8. Conclusions
The information presented in this pre-market notification demonstrates that The information probential with on of the VITROS HDL-Cholesterol Reagent and CHOL the performance or ar use with human serum and plasma is substantially equivalent to the cleared predicate device.
Equivalence was demonstrated using magnetic HDL-Cholesterol Reagent and manufactured slides along with patient and quality control samples with measured HDL-cholesterol values spanning the assay range.
The information presented in this premarket notification provide a reasonable The miorination prosition Magnetic HDL-Cholesterol Reagent and CHOL assuration that the for use with human serum and plasma is safe and effective for the stated intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers of the bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 0 2001
Ms. Marlene A. Shulman Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101
K012593 Re:
K012393
Trade/Device Name: VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent, VITROS CHOL Slide, and VITROS Chemistry Products Calibrator Kit 2
Regulation Number: 21 CFR 862.1150
Regulatory Class: II Product Code: JIS Regulation Number: 21 CFR 862.1475 Regulatory Class: I, reserved Product Code: LBR Dated: August 9, 2001 Received: August 10, 2001
Dear Mr. Shulman:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your boourer b r (=) ce (= ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of the Americans, or to devices and into t (Act). You may, therefore, market the device, subject to I coord i ood, Drug, and Goodions of the Act. The general controls provisions of the Act include the general controls pro About of usting 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 (1 Children Approval), it the Code of Federal Regulations, Title 21, Parts 800 to 895. allecting your determination assumes compliance with the Good Manufacturing A Substantally equivalent avoilable (GMP) regulation (21 CFR Part 820) and that, through I ractive for Mourcal toos, the Food and Drug Administration (FDA) will verify such perfour offirms, Failure to comply with the GMP regulation may result in regulatory action. In assumptions: That are to centry ther announcements concerning your device in the Federal adultion, I Dri may paches 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 ally Controll Journageation Control provisions, or other Federal laws or regulations.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket This lotter will and in your distantial equivalence of your device to a legally marketed nouthoute 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 11 you desire books an 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, (201) 594-1500. I radiation f 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 monfacturers 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 Sutman
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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Statement of Intended Use
Page 1 of 1
| 510(k) Number (if known): | K012593 |
|---|---|
| Device Name: | VITROS Chemistry Products Magnetic HDL-CholesterolReagentVITROS CHOL SlideVITROS Chemistry Products Calibrator Kit 2 |
| Intended Use: | For in vitro diagnostic use only.The VITROS Magnetic HDL-Cholesterol Reagent and VITROSCHOL Slides quantitatively measure HDL cholesterol (HDLC)concentration in serum and plasma. |
| VITROS Calibrator Kit 2 | |
| For in vitro diagnostic use only.VITROS Calibrator Kit 2 is intended for use in calibration of theVITROS Chemistry Systems for the quantitative measurementof CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG. | |
| Summary and Explanation ofTest: | HDL cholesterol is used to evaluate the risk of developingcoronary heart disease (CHD). The risk of CHD increases withlower HDL cholesterol concentrations. |
(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)
OR
Over-The-Counter Use __
Keria Alexander for Joan Cooper
(Division Sign-Off)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012593
§ 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.