(50 days)
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human ferritin in serum and plasma.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia.
A particle enhanced immunoturbidimetric assay in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 552 nm.
Here's a summary of the acceptance criteria and study information for the Ferritin Generation 2 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the performance of the Ferritin Generation 2 is demonstrated by direct comparison to a predicate device (COBAS Integra Ferritin assay, K963292). The assumption is that matching or improving upon the predicate's performance indicates substantial equivalence and meets acceptance.
| Feature | Implicit Acceptance Criteria (Relative to Predicate) | Ferritin Generation 2 Performance | Predicate Device Performance (COBAS Integra Ferritin) |
|---|---|---|---|
| Precision | Similar or improved CVs | Within run CV: 9.0% @ 19.8 ng/ml 2.5% @ 107.5 ng/ml Between Day CV: 7.8% @ 20.3 ng/ml 3.4% @ 157.0 ng/ml | Within run CV: 9.9% @ 19 ng/ml 1.2% @ 260 ng/ml Between Day CV: 10.2% @ 19 ng/ml 3.8% @ 260 ng/ml |
| Method Comparison | Strong correlation (r-value close to 1) and linear agreement with predicate | Bablok/Passing: $y = 1.30x + 12.98$ ng/ml $r = 0.922$ | Bablok/Passing: $y = 0.84x + 0.8$ ng/ml $r = 0.992$ (vs. commercially available system) |
| Limitations | No significant interference / similar limitations | Icterus: No significant interference Hemolysis: No significant interference up to 596 µmol/l Lipemia: No significant interference up to 160 mg/dL Rheumatoid factors: No significant interference | Icterus: No significant interference Hemolysis: No significant interference Lipemia: No significant interference Rheumatoid factors: No significant interference |
| Prozone Effect | Similar or improved high-end detection | No effect up to 10,000 ng/ml | Integra 400/400 plus: No effect up to 4300 ng/ml Integra 700/800: No effect up to 45,000 ng/ml |
| Analytical Sensitivity (LDL) | Similar or improved lower detection limit | 7.5 ng/ml | 5 ng/ml |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for any of the performance studies. It only presents the results of these studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available in the provided text. The studies relate to the performance of an in vitro diagnostic reagent system (a lab test), not an imaging-based or clinical diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not available in the provided text. Adjudication methods are typically relevant for studies involving human interpretation of results, which is not the primary focus of this device's performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
An MRMC comparative effectiveness study was not done. This type of study is not applicable to an in-vitro diagnostic reagent system like Ferritin Generation 2, which produces quantitative numerical results rather than interpretations requiring human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance evaluations of the diagnostic reagent system itself. The precision, method comparison, and interference studies assess the device's analytical performance independent of human interpretation beyond standard laboratory procedures (e.g., pipetting, running the instrument).
7. The Type of Ground Truth Used
For the Method Comparison study, the "ground truth" for the Ferritin Generation 2 device was a predicate device, specifically the COBAS Integra Ferritin assay. The comparison assessed how closely the new device's measurements correlated with the established predicate.
For other analytical performance characteristics (Precision, Limitations, Prozone Effect, Analytical Sensitivity), the "ground truth" implicitly refers to the true analytical values of the samples being tested, typically derived from reference materials or highly accurate reference methods, although these are not explicitly detailed. The device is designed to quantitatively determine human ferritin, and the ground truth would be the actual ferritin concentration in the samples.
8. The Sample Size for the Training Set
This information is not available in the provided text. This device is a reagent system, not an AI/ML-based algorithm that typically has a "training set" in the conventional sense. Its development would involve analytical testing and validation rather than a data training process.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is not an AI/ML system with a "training set." The performance characteristics are established through various analytical validation studies using reference materials and patient samples.
{0}------------------------------------------------
K03/650
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 RoadIndianapolis, IN 46250(317) 521 - 3544 |
| Contact Person: Kay A. Taylor | |
| Date Prepared: May 27, 2003 | |
| Device Name | Proprietary name: Ferritin Generation 2 |
| Common name: Ferritin | |
| Classification name: Ferritin, Antigen, Antiserum, Control | |
| DeviceDescription | A particle enhanced immunoturbidimetric assay in which human ferritinagglutinates with latex particles coated with anti-ferritin antibodies. Theprecipitate is determined turbidimetrically at 552 nm. |
| Intended use | In vitro diagnostic reagent system intended for use on COBAS Integra systemfor the quantitative immunological determination of human ferritin in serumand plasma. |
| Indications forUse | Measurements of ferritin aid in the diagnosis of diseases affecting ironmetabolism such as hemochromatosis (iron overload) and iron deficiencyanemia. |
| SubstantialEquivalence | The Ferritin Generation 2 is substantially equivalent to other devices legallymarketed in the United States. We claim equivalence to the COBAS IntegraFerritin assay (K963292). Both products are intended for use in thequantitative determination of Ferritin on automated clinical chemistryanalyzers. |
:
and the control of the comments of the control of
{1}------------------------------------------------
510(k) Summary, Continued
Substantial equivalence similarities
The following table compares the Ferritin Generation 2 Assay with the predicate device.
| Feature | Ferritin Generation 2 | Ferritin(predicate) |
|---|---|---|
| Intended Use | In vitro diagnostic reagentsystem intended for use onCOBAS INTEGRA systemfor the quantitativeimmunologicaldetermination of humanferritin in serum and plasma. | In vitro diagnostic reagentsystem intended for use onCOBAS INTEGRA systemfor the quantitativeimmunological determinationof human ferritin in serumand plasma. |
| Indication for Use | For the quantitativedetermination of ferritin inhuman serum and plasma.Measurements of ferritin aidin the diagnosis of diseasesaffecting iron metabolismsuch as hemochromatosis(iron overload) and irondeficiency anemia. | For the quantitativedetermination of ferritin inhuman serum and plasma.Measurements of ferritin aidin the diagnosis of diseasesaffecting iron metabolismsuch as hemochromatosis(iron overload) and irondeficiency anemia. |
| Assay Protocol | Particle enhancedImmunoturbidometric | Particle enhancedImmunoturbidometric |
| Instrument | COBAS Integra ClinicalChemistry Analyzers | COBAS Integra ClinicalChemistry Analyzers |
| Sample Type | Serum and plasma | Serum and plasma |
| Formulation | R: Glycine buffer stabilizedwith 0.09% sodium azide,5mg/ml rabbit globulin invial B (liquid).R2: Latex particles coatedwith anti-human ferritin(rabbit) in glycine buffer,stabilized with 0.09%sodium azide in vial C(liquid). | R: Glycine buffer stabilizedwith 0.09% sodium azide invial B (liquid).R2: Latex particles coatedwith anti-human ferritin(rabbit) in glycine buffer,stabilized with 0.09% sodiumazide in vial C (liquid). |
| Calibrator | FERR T Standard | FERR T Standard |
| Controls | FERR /MYO T Control | FERR /MYO T Control |
| Reagent Stability | On board: 12 weeks | On-board: 12 weeks |
| Feature | Ferritin Generation 2 | Ferritin(predicate) |
| Expected Values | Females: 15-150 ng/mlMales: 30-400 ng/ml(3 mos-16 yrs):20-200 ng/ml(2nd-3rd month):80-500 ng/ml(1st month):150-400 ng/ml(umbilical cord blood):50-250 ng/ml | Females: 10-120 ng/mlMales: 20-300 ng/ml |
| Measuring Range | 0-382 ng/ml | Integra 400: 0-280 ng/mlIntegra 700: 0-300 ng/ml |
| Traceability /Standardization | Standardized against theNIBSC Reagents for Ferritin(human spleen 80/578). | Traceable to WHOReference Preparation forHuman Liver Ferritin (1stInternational Standard 1984) |
| Calibration Interval | After each lot and 84 days | After each lot |
23
{2}------------------------------------------------
510(k) Summary, Continued
Substantial equivalence differences
The following table compares the Ferritin Generation 2 Assay with the predicate device.
{3}------------------------------------------------
510(k) Summary, Continued
Substantial equivalence performance characteristics The performance characteristics of the Ferritin Generation 2 Assay and the predicate device are compared in the table below.
| Feature | Ferritin Generation 2 | Apolipoprotein B(predicate) |
|---|---|---|
| Precision | Within run CV9.0% @ 19.8 ng/ml2.5% @ 107.5 ng/mlBetween Day CV7.8% @ 20.3 ng/ml3.4% @ 157.0 ng/ml | Within run CV9.9% @ 19 ng/ml1.2% @ 260 ng/mlBetween Day CV10.2% @ 19 ng/ml3.8% @ 260 ng/ml |
| Method Comparison | Bablok/Passing:Ferritin Generation 2 (Y) /COBAS Integra Ferritin (X).$y = 1.30x + 12.98$ ng/ml$r = 0.922$ | Bablok/Passing:Ferritin (Y)/commercially availablesystem (X).$y = 0.84x + 0.8$ ng/ml$r = 0.992$ |
| Limitations | • Icterus: No significantinterference• Hemolysis: Nosignificant interferenceup to a level 596 µmol/l.• Lipemia: No significantinterference up to anIntralipid level of 160mg/dL• Rheumatoid factors: Nosignificant interference | • Icterus: No significantinterference• Hemolysis: Nosignificantinterference• Lipemia: Nosignificantinterference• Rheumatoid factors:No significantinterference |
| Prozone Effect | No effect up to 10,000 ng/ml | Integra 400/400 plus:No effect up to 4300 ng/mlIntegra 700 /800:No effect up to 45,000ng/ml |
| Analytical sensitivity(LDL) | 7.5 ng/ml | 5 ng/ml |
:
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest movement or flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kay A. Taylor, MT (ASCP), RAC Regulatory Program Principal Centralized Diagnostic Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis. Indiana 46250-0457
JUL 17 2003
Re: K031650
Trade/Device Name: Roche COBAS Integra Ferritin Generation 2 Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: II Product Code: DBF Dated: July 7, 2003 Received: July 9, 2003
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 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. Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code 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 comply with all the 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). 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.
{5}------------------------------------------------
Page 2 --
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Ferritin Generation 2 Test System
Indications For Use:
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human ferritin in serum and plasma.
Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
J. Reeve for J. Bautista
Division Sign-Off
Division Sign-Off
ice of In Vitro Diagnostic Evaluation and
510(k) K031650
20
§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).