(61 days)
System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.
For in vitro diagnostic use.
In this Olympus procedure:
When a sample is mixed with R1 buffer and R2 antiserum solution, human IgA reacts specifically with anti-human IgA antibodies to yield insoluble aggregates.
Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.
Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.
In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Olympus IgA Reagent (OSR6X171):
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Olympus IgA (OSR6X171) reagent) |
|---|---|---|
| Precision (Total CV%) | ||
| AU400/400e Sample 1 | As good as or better than 1.53% | 2.43% |
| AU400/400e Sample 2 | As good as or better than 1.63% | 2.52% |
| AU400/400e Sample 3 | As good as or better than 1.26% | 2.95% |
| AU600/640/640e Sample 1 | As good as or better than 1.38% | 3.39% |
| AU600/640/640e Sample 2 | As good as or better than 1.08% | 3.85% |
| AU600/640/640e Sample 3 | As good as or better than 1.81% | 4.01% |
| AU2700/5400 Sample 1 | As good as or better than 2.64% | 1.50% |
| AU2700/5400 Sample 2 | As good as or better than 2.05% | 1.91% |
| AU2700/5400 Sample 3 | As good as or better than 3.29% | 1.83% |
| Assay Range | 10 to 700 mg/dL | 10 to 700 mg/dL |
| LoQ | Not specified (or comparable to predicate) | 10 mg/dL |
| Method Comparison (Linear Regression) | ||
| Intercept | Comparable to 1.3 mg/dL | 15.1 mg/dL |
| Slope | Comparable to 0.957 | 0.923 |
| R^2 | Comparable to 0.99 | 0.999 |
| N | Comparable to 94 | 111 |
| Range | Comparable to 54-660 mg/dL | 38-672 mg/dL |
| Interfering Substances | ||
| Bilirubin (AU400/400e) | Interference < 2% up to 40 mg/dL | Interference < 2% up to 40 mg/dL |
| Hemolysate (AU400/400e) | Interference < 2% up to 500 mg/dL | Interference < 1% up to 500 mg/dL |
| Lipemia (AU400/400e) | Interference < 10% up to 600 mg/dL | Interference < 10% up to 1000 mg/dL |
| RF (AU400/400e) | Not specified | Interference < 8% up to 600 IU/mL |
| Bilirubin (AU600/640/640e) | Interference < 5% up to 40 mg/dL | Interference < 3% up to 40 mg/dL |
| Hemolysate (AU600/640/640e) | Interference < 2% up to 500 mg/dL | Interference < 5% up to 500 mg/dL |
| Lipemia (AU600/640/640e) | Interference < 7% up to 1000 mg/dL | Interference < 6% up to 1000 mg/dL |
| RF (AU600/640/640e) | Not specified | Interference < 8% up to 600 IU/mL |
| Bilirubin (AU2700/5400) | Interference < 5% up to 40 mg/dL | Interference < 3% up to 40 mg/dL |
| Hemolysate (AU2700/5400) | Interference < 3% up to 500 mg/dL | Interference < 4% up to 500 mg/dL |
| Lipemia (AU2700/5400) | Interference < 10% up to 1000 mg/dL | Interference < 4% up to 1000 mg/dL |
| RF (AU2700/5400) | Not specified | Interference < 4% up to 600 IU/mL |
| Ascorbic Acid | Interference < 2-3% up to 20 mg/dL | Not tested |
| Prozone Capacity | No high dose effect up to 3,200 mg/dL | No high dose effect up to 10,000 mg/dL |
Note: Acceptance criteria are inferred based on the performance of the predicate device, as the document states "The following Tables compare the new Olympus IgA (OSR6X171) reagent with the predicate devices..." implying that comparable performance to the predicate is the acceptance standard for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Precision: The sample sizes for the precision studies are not explicitly stated, but "Sample 1," "Sample 2," and "Sample 3" for each instrument suggest multiple measurements were taken for each of these samples. The number of replicates per sample and the total number of samples tested are not provided.
- Method Comparison (Linear Regression): N = 111 samples were used for the method comparison study.
- Interfering Substances: The sample sizes for interference studies are not provided.
- Prozone Capacity: The sample sizes for prozone capacity testing are not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission, it is typically based on prospective studies conducted in controlled laboratory settings for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes an in vitro diagnostic (IVD) reagent, not an AI/CADe device that uses expert-established ground truth from medical images. Therefore, this information is not applicable. For IVDs, the "ground truth" is typically established through reference methods or highly accurate comparative assays. In this case, the predicate device (Olympus IgA (OSR6X44) Reagent) served as the comparator for method comparison, and the "calibration traceability" to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619) provides the ultimate "ground truth" for the quantitative measurements.
4. Adjudication Method for the Test Set
Not applicable, as this is an IVD reagent and not an AI/CADe device involving human expert adjudication.
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
Not applicable. This is an IVD reagent, not an AI/CADe device, and does not involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is an IVD reagent that performs quantitative measurements on Olympus analyzers. Its performance is inherently standalone in the sense that the measurement results are generated by the instrument and reagent system without human interpretation for the determination of the IgA level itself. The physician then interprets these quantitative results in a clinical context. The performance characteristics described (precision, assay range, method comparison, interference, prozone capacity) all reflect the standalone performance of the reagent on the specified analyzers.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the quantitative determination of IgA, the "ground truth" is implicitly established by:
- Traceability to an International Reference Preparation: The method is traceable to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619). This serves as the primary reference standard for accurate IgA quantification.
- Comparison to a Legally Marketed Predicate Device: The performance is compared against the previously approved Olympus IgA (OSR6X44) Reagent (K951055), which itself would have been validated against accepted reference methods and standards.
8. The Sample Size for the Training Set
Not applicable. This is an IVD reagent, not a machine learning or AI device that uses a "training set" in the conventional sense. The development of such a reagent involves chemical formulation and analytical validation, not algorithm training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The accuracy of the reagent is validated against established quantitative standards and predicate device performance.
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510(k) Summary
This summary of the 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: KOJ3489
| 1. Submitter name, address, contact | Olympus America Inc.3500 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| U.S. Telephone: 469-230-0959U.S. Fax: 972-317-7861 | |
| Contact Person: Stephanie G. Donnelly | |
| Date Prepared: December 10, 2007 | |
| 2. Device name | Proprietary Name: Olympus IgA Reagent (OSR6X171) |
| Common Name: IgA reagent | |
| Classification Name: IgA, Antigen, Antiserum, Control | |
| 3. Predicate device | Reagent: Olympus (OSR6X44) IgA ReagentSubmitted K951055 |
| 4. Device description | In this Olympus procedure: When a sample is mixed with R1 buffer and R2 antiserum solution, human IgA reacts specifically with anti-human IgA antibodies to yield insoluble aggregates.Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction. |
| 5. Intended use | System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.For in vitro diagnostic use. |
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The following Tables compare the new Olympus IgA (OSR6X171)
reagent with the predicate devices outlined in point 3 above.
| Similarities | ||
|---|---|---|
| Item | Olympus IgA (OSR6X171) reagent | Predicate System |
| Intended Use | System reagent for the quantitativedetermination of IgA immunoglobulins inhuman serum and plasma on Olympusanalyzers | System reagent for the quantitativedetermination of IgA immunoglobulins inhuman serum on Olympus analyzers |
| Measurement | Quantitative | Same |
| Instrument Required | Olympus AU400/400e, 600/640/640e and2700/5400 | Same |
| Reagent handling | Ready for use | Same |
| AssayMethodology/OperatingPrinciple | Immunoturbidimetric | Same |
| Reagent storage form | LiquidOn --board storage | Same |
| Calibrator | Olympus Serum Protein Mulit-Calibrator(ODR3021) | Same |
| Calibration Traceability | This method is traceable to the InternationalReference Preparation CRM 470 (USdesignation RPPHS lot 91/0619) | Same |
| Antibody | Goat Anti-IgA antiserum | Same |
| Expected Values | 66-433 mg/dL | Same |
| Reagent On Board Stability | Opened reagents are stable for 90 dayswhen stored in the refrigeratedcompartment of the analyzer. | Same |
| Differences | ||
| Item | Olympus IgA (OSR6X171) reagent | Predicate System |
| Specimen Type | Serum, EDTA Plasma and Li-HeparinizedPlasma | Serum |
| Calibration Frequency | 90 days | 7 days |
| Performance Characteristics | ||||
|---|---|---|---|---|
| Item | Olympus IgA (OSR6X171) reagent | Predicate System | ||
| Precision | AU400/400e | AU400/400e | ||
| Sample | Total CV% | Sample | Total CV% | |
| 1 | 2.43 | 1 | 1.53 | |
| 2 | 2.52 | 2 | 1.63 | |
| 3 | 2.95 | 3 | 1.26 | |
| AU600/640/640e | AU600 | |||
| Sample | Total CV% | Sample | Total CV% | |
| 1 | 3.39 | 1 | 1.38 | |
| 2 | 3.85 | 2 | 1.08 | |
| 3 | 4.01 | 3 | 1.81 | |
| AU2700/5400 | AU640/640e | |||
| Sample | Total CV% | Sample | Total CV% | |
| 1 | 1.50 | 1 | 1.8 | |
| 2 | 1.91 | 2 | 1.3 | |
| 3 | 1.83 | |||
| AU2700/5400 | ||||
| Sample | Total CV% | |||
| 1 | 2.64 | |||
| 2 | 2.05 | |||
| 3 | 3.29 |
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| Assay Range | 10 to 700 mg/dL | 10 to 700 mg/dL |
|---|---|---|
| LoQ | 10 mg/dL | Not specified |
| Method Comparison(Linear Regression) | Intercept 15.1 mg/dLSlope 0.923R2 0.999N 111Range 38-672 mg/dL | Intercept 1.3 mg/dLSlope 0.957R2 0.99N 94Range 54-660 mg/dL |
| Interfering Substances | AU400/400eBilirubin: Interference less than 2% up to40 mg/dL BilirubinHemolysate: Interference less than 1% upto 500 mg/dL HemolysateLipemia: Interference less than 10% up to1000 mg/dL IntralipidRF: Interferences less than 8% up to 600IU/mLNot tested | AU400/400eBilirubin: Interference less than 2% up to40 mg/dL BilirubinHemolysate: Interference less than 2%up to 500 mg/dL HemolysateLipemia: Interference less than 10% upto 600 mg/dL IntralipidNot SpecifiedAscorbic Acid: Interferences less than2% up to 20 mg/dL Ascorbate |
| AU600/640/640eBilirubin: Interference less than 3% up to40 mg/dL BilirubinHemolysate: Interference less than 5% upto 500 mg/dL HemolysateLipemia: Interference less than 6% up to1000 mg/dL IntralipidRF: Interferences less than 8% up to 600IU/mLNot tested | AU600/640/640eBilirubin: Interference less than 5% up to40 mg/dL BilirubinHemolysate: Interference less than 2%up to 500 mg/dL HemolysateLipemia: Interference less than 7% up to1000 mg/dL IntralipidNot SpecifiedAscorbic Acid: Interferences less than2% up to 20 mg/dL Ascorbate | |
| AU2700/5400Bilirubin: Interference less than 3% up to40 mg/dL BilirubinHemolysate: Interference less than 4% upto 500 mg/dL HemolysateLipemia: Interference less than 4% up to1000 mg/dL IntralipidRF: Interferences less than 4% up to 600IU/mLNot tested | AU2700/5400Bilirubin: Interference less than 5% up to40 mg/dL BilirubinHemolysate: Interference less than 3%up to 500 mg/dL HemolysateLipemia: Interference less than 10% upto 1000 mg/dL IntralipidNot SpecifiedAscorbic Acid: Interferences less than3% up to 20 mg/dL Ascorbate | |
| Prozone Capacity | No high dose effect at IgA concentrationsup to 10, 000 mg/dL | No high dose effect at IgAconcentrations up to 3,200 mg/dL |
.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.
Public Health Service
FEB 11 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Olympus America, Inc. c/o Ms. Stephanie Donnelly Regulatory Affairs/Quality Assurance Manager Olympus Life Science Research Europa GmbH Lismeehan, O. Callaghan's Mills Co. Claire, Ireland.
Re: K073489
Trade/Device Name: Olympus IgA reagent Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E immunological test systems Regulatory Class: Class II Product Code: CFN Dated: December 11, 2007 Received: December 12, 2007
Dear Ms. Donnelly:
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. Drug. 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); 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
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Page 2 -
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) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert H. Baker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K073489
Device Name: The Olympus IgA reagent (OSR6X171).
Indication For Use: System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.
The spectrum of abnormalities in serum immunoglobulin concentrations is broad. Abnormal concentrations range from a virtual absence of one or more of the three major classes of immunoglobulin (IgG, IgA, and IgM) to polyclonal increases in one or more immunoglobulins. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.
V Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Maria M Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073489
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).