(49 days)
For in vitro quantitative determination of Apolipoprotein B in serum and plasma. Apolipoprotein B measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein B in serum and plasma for use on the INTEGRA family of analyzers.
This 510(k) submission describes a modification to an existing device, the INTEGRA Reagent Cassette for Apolipoprotein B. The key difference is the addition of plasma as an acceptable specimen type. The submission focuses on demonstrating substantial equivalence to the predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state acceptance criteria in a quantitative table format. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The claim is that the performance characteristics of the modified device are equivalent to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Precision | Equivalent to predicate device | Equivalent to predicate device (Stated in {2}) |
| Analytical Sensitivity | Equivalent to predicate device | Equivalent to predicate device (Stated in {2}) |
| Calibration Interval | Equivalent to predicate device | Equivalent to predicate device (Stated in {2}) |
| Limitations Statements | Equivalent to predicate device | Equivalent to predicate device (Stated in {2}) |
Explanation: The phrase "Performance characteristics, including precision, analytical sensitivity, calibration interval, and limitations statements for the two devices are equivalent" ({2}) serves as the core claim of meeting acceptance criteria through substantial equivalence. There are no numerical targets or ranges provided for these characteristics in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of the studies). It generally refers to "Specific data on the performance of the test" being incorporated into the draft labeling ({1}).
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 provided in the document. The device is an in vitro diagnostic for quantitative determination of Apolipoprotein B, not an imaging device or one that requires expert interpretation to establish ground truth in the same way. The "ground truth" for such a device would likely be accurate reference material values or established clinical samples with known Apolipoprotein B concentrations, rather than expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the evaluation of an in vitro diagnostic device that quantifies a biomarker. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are interpreting images or clinical data, and there's a need to resolve discrepancies in their assessments.
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
An MRMC study was not done. This device is an in vitro diagnostic for quantitative biomarker measurement, not an AI-assisted diagnostic tool that would involve human readers interpreting results in a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable in the context of this traditional in vitro diagnostic device. The INTEGRA Reagent Cassette for Apolipoprotein B is a chemical reagent system used on an analyzer, not an algorithm. Its performance is inherent to the chemical reactions and the instrument's measurement capability. The "standalone" performance would be its analytical accuracy and precision in measuring Apolipoprotein B from a sample.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "type of ground truth" used. For an in vitro diagnostic device measuring a biomarker quantitatively, the ground truth would typically be established using:
- Reference measurement procedures: Highly accurate and precise methods to determine the true concentration of Apolipoprotein B in control samples or patient samples.
- Certified reference materials: Materials with an accurately assigned value for Apolipoprotein B concentration.
- Comparison to a clinically established "gold standard" method: While the submission emphasizes substantial equivalence to the predicate device, internal validation would likely involve comparison to established methods or reference values for accuracy.
8. The sample size for the training set
This information is not provided and is generally not applicable in the context of this device. The INTEGRA Reagent Cassette for Apolipoprotein B is a reagent system, not a machine learning model that requires a "training set." The development of such a system involves formulation, optimization, and validation, but not typically in the sense of a dataset to train an algorithm.
9. How the ground truth for the training set was established
This information is not provided and is generally not applicable for the reasons mentioned in point 8.
Summary of Study Type:
This submission describes a substantial equivalence study for a modification to an in vitro diagnostic reagent. The study's primary goal is to demonstrate that the modified device, which now accepts both serum and plasma, performs equivalently to the previously cleared device, which only accepted serum. The "study" involves generating performance data (precision, analytical sensitivity, etc.) on the modified device and showing that these characteristics are comparable to the predicate device's established performance. The document explicitly states that "Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission," but these detailed results are not included in the provided snippets.
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APR 1 4 1959
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510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis, IN 46250(317) 576-3723Contact person: Priscilla A. HamillDate prepared: February 23, 1999 |
| Device name | Proprietary name: INTEGRA Reagent Cassette for Apolipoprotein BCommon name: Apolipoprotein BClassification name: Lipoprotein Test System |
| Predicate device | We claim substantial equivalence to the currently marketed Roche INTEGRA Reagent Cassette for Apolipoprotein B. |
| Device description | The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein B in serum and plasma for use on the INTEGRA family of analyzers. |
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510(k) Summary, Continued
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| Intended use | For in vitro quantitative determination of Apolipoprotein B in serum and plasma |
|---|---|
| Substantial equivalence – similarities | The INTEGRA Reagent Cassette for Apolipoprotein B is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche INTEGRA Reagent Cassette for Apolipoprotein B (K951595) |
| The following table illustrates the similarities between the modified INTEGRA Reagent Cassette for Apolipoprotein B and the predicate device. Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission. Labeling for the predicate device is provided in Section VI. |
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510(k) Summary, Continued
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| Feature | Modified Device | Predicate Device | |
|---|---|---|---|
| Intended use | For the quantitativedetermination ofApolipoprotein B. | For the quantitativedetermination ofApolipoprotein B. | |
| Indicationsfor use | Apolipoprotein Bmeasurements are used in thediagnosis and treatment oflipid disorders (such asdiabetes mellitus),atherosclerosis, and variousliver and renal diseases. | Apolipoprotein Bmeasurements are used in thediagnosis and treatment of lipiddisorders (such as diabetesmellitus), atherosclerosis, andvarious liver and renal diseases. | |
| Methodology | Immunoturbidimetric | Immunoturbidimetric | |
| Measure-mentapproach | Spectrophotometric | Spectrophotometric | |
| Instrumentrequired | INTEGRA family of analyzers | INTEGRA family of analyzers | |
| Measuringrange | 0.26-3.9 g/L0.09-7.8 g/L with rerun | 0.26-3.9 g/L0.09-7.8 g/L with rerun | |
| Formulation | Anti-apolipoprotein B Tantiserum (sheep) specific forhuman apolipoprotein B inphosphate buffer stabilizedwith 0.09% sodium azide. | Anti-apolipoprotein B Tantiserum (sheep) specific forhuman apolipoprotein B inphosphate buffer stabilizedwith 0.09% sodium azide. | |
| Substantialequivalence -differences | The modified device differs from the predicate device in that plasma is nowclaimed as an acceptable specimen type. | ||
| The following table illustrates the differences between the INTEGRA ReagentCassette for Apolipoprotein B and the predicate device. | |||
| Feature | Modified Device | Predicate Device | |
| Sample type | Serum and plasma | Serum | |
| Substantialequivalence -performancecharacteristics | Performance characteristics, including precision, analytical sensitivity,calibration interval, and limitations statements for the two devices areequivalent. |
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Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are designed to resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
APR 1 4 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
Re: K990595 Trade Name: INTEGRA Reagent Cassette for Apolipoprotein B : Regulatory Class: II Product Code: DFC Dated: February 23, 1999 Received: February 24, 1999
Dear Ms. Hamill:
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 (for the indications for use stated in the enclosure) to legally marketed predicate 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
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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S10(k) Number (if known): ___
K 990593
Device Name: INTEGRA Reagent Cassette for Apolipoprotein B
Indications for Üse:
For the quantitative determination of apolipoprotein B 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 and atherosclerosis.
Sean Coogan
(Division Sign-Off)
Division of Clinical Laboratory Devices Knights Hyly 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-the-Counter Use
(Optional format 1-2-96)
§ 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).