(49 days)
For in vitro quantitative determination Apolipoprotein A-1 in serum and plasma.
Apolipoprotein A-1 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 A-1 in serum and plasma for use on the INTEGRA family of analyzers.
This 510(k) summary describes a device that is substantially equivalent to a previously marketed device, rather than providing independent acceptance criteria and a study proving the device meets those criteria. The submission focuses on demonstrating the similarities between the modified device and its predicate, implying that if the predicate device met acceptance criteria, the modified device, being similar, also meets them.
Therefore, many of the requested sections (acceptance criteria, device performance values, sample sizes, expert qualifications, adjudication, MRMC studies, standalone studies, ground truth types for test and training sets) cannot be directly extracted as they are not explicitly stated for the modified device in this document. The document argues for substantial equivalence primarily on the basis of identical intended use, indications for use, methodology, instrument, measuring range, and formulation.
However, I can extract the information provided regarding the similarities and the study supporting the substantial equivalence claim.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission, K990594, focuses on demonstrating substantial equivalence to a previously marketed predicate device (Roche INTEGRA Reagent Cassette for Apolipoprotein A-1, K954992) rather than establishing new, specific acceptance criteria for the modified device and then conducting a study to prove it meets them. The "study" here is a comparison demonstrating that the modified device is fundamentally the same as its predicate in key performance and design aspects.
The key argument is that because the predicate device was already deemed safe and effective, and the modified device is substantially equivalent to the predicate, the modified device also meets the necessary safety and effectiveness requirements.
1. Table of Acceptance Criteria and Reported Device Performance
As the document is a substantial equivalence submission, it does not define new acceptance criteria for the modified device, nor does it provide a new performance study with specific performance values against new acceptance criteria. Instead, it highlights the similarities between the modified device and its predicate, implying that the predicate's established performance serves as the benchmark.
| Feature / Criteria (Implied) | Modified Device Performance (Reported) | Predicate Device Performance (Reference) |
|---|---|---|
| Intended Use | For the quantitative determination of Apolipoprotein A-1 in serum and plasma. | For the quantitative determination of Apolipoprotein A-1 in serum and plasma. |
| Indications for Use | Apolipoprotein A-1 measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. | Apolipoprotein A-1 measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. |
| Methodology | Immunoturbidimetric Spectrophotometric | Immunoturbidimetric Spectrophotometric |
| Instrument Required | INTEGRA family of analyzers | INTEGRA family of analyzers |
| Measuring Range | 0.37-4.0 g/L (0.12-5.6 g/L with rerun) | 0.37-4.0 g/L (0.12-5.6 g/L with rerun) |
| Formulation | Anti-apolipoprotein A-1 T antiserum (sheep) specific for human apolipoprotein A-1 in phosphate buffer stabilized with 0.09% sodium azide. | Anti-apolipoprotein A-1 T antiserum (sheep) specific for human apolipoprotein A-1 in phosphate buffer stabilized with 0.09% sodium azide. |
Note: The "reported device performance" here is the design and functional specification of the modified device, which is presented as identical to the predicate device. Specific numerical performance data (e.g., accuracy, precision, linearity) for the modified device itself are stated as being "incorporated into the draft labeling in Section V of this submission," but are not provided in this 510(k) summary itself. The core of the argument is that since these features are identical, the performance will be equivalent.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for a "test set" for the modified device, nor its data provenance. The summary focuses on showing design and functional equivalence to the predicate. The "specific data on the performance of the test" is mentioned as being in Section V of the submission, but not summarized here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of substantial equivalence submission. There is no mention of experts establishing a ground truth for a test set in this document.
4. Adjudication Method for the Test Set
Not applicable for this type of substantial equivalence submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is an in vitro diagnostic reagent, not an imaging or interpretation device that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device is an "algorithm only" in the sense of being an automated chemical assay, the document does not present a standalone performance study with specific metrics for the modified device in this summary. Instead, it relies on the predicate's established performance to argue for substantial equivalence. The summary states that "Specific data on the performance of the test have been incorporated into the draft labeling in Section V of this submission." This would likely contain data on precision, accuracy, linearity, etc., similar to a standalone study for the modified device, but these details are not provided in the 510(k) summary itself.
7. The Type of Ground Truth Used
Not applicable in the context of this summary. For an immunoturbidimetric assay, "ground truth" would typically refer to a reference method or a highly accurate comparative method used during validation studies (presumably for the predicate device and the modified device's internal validation), but this is not detailed in the summary.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that utilizes training sets in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
{0}------------------------------------------------
长990594
APR 1 4 1999
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis, IN 46250(317) 576-3723 |
| Contact person: Priscilla A. Hamill | |
| Date prepared: February 23, 1999 | |
| Device name | Proprietary name: INTEGRA Reagent Cassette for Apolipoprotein A-1 |
| Common name: Apolipoprotein A-1 | |
| Classification name: Lipoprotein test system | |
| Predicatedevice | We claim substantial equivalence to currently marketed Roche INTEGRAReagent Cassette for Apolipoprotein A-1. |
| Devicedescription | The device is an immunoturbidimetric test for the quantitative determinationof Apolipoprotein A-1 in serum and plasma for use on the INTEGRA familyof analyzers. |
| Continued on next page |
{1}------------------------------------------------
510(k) Summary, Continued
: 代
| Intended use | For in vitro quantitative determination Apolipoprotein A-1 in serum andplasma. |
|---|---|
| Substantialequivalence --similarities | The Roche INTEGRA Reagent Cassette for Apolipoprotein A-1 issubstantially equivalent to other products in commercial distribution intendedfor similar use. Most notably, it is substantially equivalent to the currentlymarketed Roche INTEGRA Reagent Cassette for Apolipoprotein A-1(K954992) |
| The following table illustrates the similarities between modified INTEGRAApolipoprotein A-1 and the predicate device. Specific data on theperformance of the test have been incorporated into the draft labeling inSection V of this submission. Labeling for the predicate device is provided inSection VI. | |
| Continued on next page. |
のお気になる。
:
,
:
.
{2}------------------------------------------------
. *
510(k) Summary, Continued
Art
。 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
| Feature | Modified Device | Predicate Device |
|---|---|---|
| Intended use | For the quantitativedetermination ofApolipoprotein A-1. | For the quantitativedetermination ofApolipoprotein A-1. |
| Indicationsfor use | Apolipoprotein A-1measurements are used in thediagnosis and treatment oflipid disorders (such asdiabetes mellitus),atherosclerosis, and variousliver and renal diseases. | Apolipoprotein A-1measurements are used in thediagnosis and treatment of lipiddisorders (such as diabetesmellitus), atherosclerosis, andvarious liver and renal diseases. |
| MethodologyMeasure-mentapproach | ImmunoturbidimetricSpectrophotometric | ImmunoturbidimetricSpectrophotometric |
| Instrumentrequired | INTEGRA family of analyzers | INTEGRA family of analyzers |
| Measuringrange | 0.37-4.0 g/L0.12-5.6 g/L with rerun | 0.37-4.0 g/L0.12-5.6 g/L with rerun |
| Formulation | Anti-apolipoprotein A-1 Tantiserum (sheep) specific forhuman apolipoprotein A-1 inphosphate buffer stabilizedwith 0.09% sodium azide. | Anti-apolipoprotein A-1 Tantiserum (sheep) specific forhuman apolipoprotein A-1 inphosphate buffer stabilizedwith 0.09% sodium azide. |
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines, representing health and well-being.
APR 1 4 1999
Ms. Priscilla A. Hamill Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
K990594 Re:
Trade Name: INTEGRA Reagent Cassette for Apolipoprotein A-1 Regulatory Class: II Product Code: DER 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 QS 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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
{4}------------------------------------------------
Page 2
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 Autman
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
{5}------------------------------------------------
K990594 510(k) Number (if known):
Device Name: INTEGRA Reagent Cassette for Apolipoprotein A-1
Indications for Use:
For the quantitative determination of apolipoprotein A-1 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.
han Coogn
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K990594
(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)
§ 866.5580
Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).