(61 days)
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No
The device description and performance studies focus on standard turbidimetric assay principles and analytical performance metrics, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) system reagent used for the quantitative determination of IgM immunoglobulins in human serum and plasma, which aids in diagnosis rather than directly treating or mitigating disease.
Yes.
The "Intended Use" states that the product is "For in vitro diagnostic use," which is a clear indicator of a diagnostic device.
No
The device is a system reagent for in vitro diagnostic use, which involves chemical reactions and measurement of light transmission, indicating it is a physical reagent and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use."
- Nature of the Device: The device is a "System reagent for the quantitative determination of IgM immunoglobulins in human serum and plasma". This describes a reagent used to analyze biological samples outside of the body to provide diagnostic information.
- Mechanism of Action: The "Device Description" explains how the reagent interacts with the sample (antigen-antibody reaction) to produce a measurable result (turbidity), which is a common principle in in vitro diagnostic tests.
- Performance Studies: The document includes performance characteristics like precision, assay range, method comparison, and interference testing, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K950900) indicates that this device is being compared to a previously cleared IVD device, further confirming its classification.
All these points strongly support the conclusion that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
System reagent for the quantitative determination of IgM immunoglobulins in human serum and plasma on OLYMPUS analyzers.
For in vitro diagnostic use.
Product codes
CFN
Device Description
In this Olympus procedure:
- When a sample is mixed with R1 buffer and R2 antiserum solution, human IgM reacts specifically with anti-human IgM 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison data against the predicate system is provided for Precision, Assay Range, Prozone, Method Comparison (Linear Regression), Interfering Substances, and Function Sensitivity.
Precision:
AU400/400e: Sample 1 (4.03 Total CV%), Sample 2 (2.95 Total CV%), Sample 3 (2.60 Total CV%)
AU600/640/640e: Sample 1 (3.44 Total CV%), Sample 2 (3.29 Total CV%), Sample 3 (4.08 Total CV%)
AU2700/5400: Sample 1 (3.79 Total CV%), Sample 2 (3.31 Total CV%), Sample 3 (3.52 Total CV%)
Assay Range: 20-500 mg/dL
Prozone: Hook effect may occur with highly elevated IgM samples > 10,000 mg/dL polyclonal.
Method Comparison (Linear Regression): Slope 1.006, Intercept 2.8, R 1.000, N 107, Range 22-468 mg/dL.
Interfering Substances:
AU400/400e: Bilirubin (Interference less than 4% up to 40 mg/dL), Hemolysis (Interference less than 4% up to 500 mg/dL Hemolysate), Lipemia (Interference less than 10% up to 300 mg/dL Intralipid). Ascorbic Acid: Not Tested.
AU600/640/640e: Bilirubin (Interference less than 3% up to 40 mg/dL), Hemolysis (Interference less than 3% up to 500 mg/dL Hemolysate), Lipemia (Interference less than 10% up to 300 mg/dL Intralipid). Ascorbic Acid: Not Tested.
AU2700/5400: Bilirubin (Interference less than 8% up to 40 mg/dL), Hemolysis (Interference less than 3% up to 500 mg/dL Hemolysate), Lipemia (Interference less than 10% up to 200 mg/dL Intralipid). Ascorbic Acid: Not Tested.
Function Sensitivity:
§ 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).
0
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.
1990 and 21 CC (CCC
| The assigned 510(k) number is: | K073486 |
|---|---|
| -------------------------------- | --------- |
| 1. Submitter name, address, contact | Olympus America Inc.
3500 Corporate Parkway
Center Valley, PA 18034 |
|-------------------------------------|---------------------------------------------------------------------------|
| U.S. Telephone: | 469-230-0959 |
| U.S. Fax: | 972-317-7861 |
| Contact Person: | Stephanie G. Donnelly |
| Date Prepared: | December 11, 2007 |
FEB 11 2008
| 2. Device name | |
|---|---|
| Proprietary Name: | Olympus IgM reagent (OSR6X173) |
| Common Name: | IgM reagent |
| Classification Name: | IgM (mu chain specific), antigen, antiserum, control. |
| 3. Predicate device | |
| Reagent: | Olympus (OSR6X46) IgM Reagent Submitted K950900 |
| 4. Device description | In this Olympus procedure: |
- When a sample is mixed with R1 buffer and R2 antiserum solution, human IgM reacts specifically with anti-human IgM 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 IgM immunoglobulins in human serum and plasma on OLYMPUS analyzers.
For in vitro diagnostic use. |
| ----------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
1
The following Tables compare the new Olympus IgM (OSR6X173) reagent
with the predicate device outlined in point 3 above.
| Similarities | ||
|---|---|---|
| Item | Olympus IgM (OSR6X173) reagent | Predicate System |
| Intended Use | System reagent for the quantitative | |
| determination of IgM immunoglobulins | ||
| in human serum and plasma on | ||
| OLYMPUS analyzers. | System reagent for the quantitative | |
| determination of IgM immunoglobulins | ||
| in human serum on OLYMPUS | ||
| analyzers. | ||
| Instrument | Olympus AU400/400°, 600/640/640° | |
| and 2700/5400 | Same | |
| Measurement | Quantitative | Same |
| Reagent handling | Ready for use | Same |
| Assay | ||
| Methodology/Operating | ||
| Principle | Immunoturbidimetric | Same |
| Antibody | Goat anti-IgM antiserum | Same |
| Reagent storage form | Liquid | |
| On-board storage | Same | |
| On-Board Stability | 90 days | Same |
| Calibrator | Olympus Serum Protein Mulit- | |
| Calibrator (ODR3021) | Same | |
| Calibrator Traceability | This method is traceable to the | |
| International Reference Preparation | ||
| CRM470 (US designation RPPHS lot | ||
| 91/06/19) | Same | |
| Calibration Frequency | 90 days | Same |
| Expected Values | 45-281 mg/dL | Same |
| Differences | ||
| Item | Olympus IgM (OSR6X173) reagent | Predicate System |
| Specimen Type | Serum and plasma: Li-heparin and | |
| EDTA plasma | Serum |
| Item | Performance Characteristics
Olympus IgM (OSR6X173) reagent | Predicate System |
|-----------|---------------------------------------------------------------|----------------------|
| Precision | AU400/400e
Sample | AU400/400e
Sample |
| | 1
2
3 | 1
2
3 |
| | Total CV% | Total CV% |
| | 4.03
2.95
2.60 | 1.74
1.18
1.49 |
| | AU600/640/640e
Sample | AU600
Sample |
| | 1
2
3 | 1
2
3 |
| | Total CV% | Total CV% |
| | 3.44
3.29
4.08 | 2.16
1.48
1.35 |
| | | AU640/640e
Sample |
| | | 1
2 |
| | | Total CV% |
| | | 1.5
1.3 |
రి.
.
2
| AU2700/5400 | AU2700/5400 | |
|---|---|---|
| Sample | ||
| Total CV% | Sample | |
| Total CV% | ||
| 3.79 | ||
| 1 | 1 | |
| 2.49 | ||
| 2 | ||
| 3.31 | 2 | |
| 2.57 | ||
| Assay Range | 3 | |
| 3.52 | ||
| 20-500 mg/dL | 3 | |
| 3.07 | ||
| Hook effect may occur with highly elevated | Same | |
| Hook effect may occur with highly elevated | ||
| Prozone | IgM samples > 10, 000 mg/dL polyclonal | IgM samples > 3, 500 mg/dL polyclonal |
| Slope | ||
| 1.006 | Slope | |
| 0.968 | ||
| Method Comparison (Linear | Intercept | |
| 2.8 | Intercept | |
| 0.6 | ||
| Regression) | R | |
| 1.000 | R | |
| 0.998 | ||
| N | ||
| 107 | ക്ക | |
| Z | ||
| Interfering Substances | 22-468 mg/dL | |
| Range | ||
| AU400/4006 | Range | |
| 24-497 mg/dL | ||
| AU400/4008 | ||
| Bilirubin: Interference less than 4% up to | Bilirubin: Interference less than 2% up to 40 | |
| 40 mg/dL Bilirubin | mg/dL Bilirubin | |
| Hemolysis: Interference less than 4% up to | Hemolysis: Interference less than 2% up to | |
| 500 mg/dL Hemolysate | 500 mg/dL Hemolysate | |
| Lipemia: Interference less than 10% up to | Lipemia: Interference less than 10% up to | |
| 300 mg/dL Intralipid | 300 mg/dL Intralipid | |
| Not Tested | Ascorbic Acid: Interference less than 2% up | |
| to 20 mg/dL Ascorbate | ||
| AU600/640/640° | AU600/640/640 | |
| Bilirubin: Interference less than 3% up to | Bilirubin: Interference less than 5% up to 40 | |
| 40 mg/dL Bilirubin | mg/dL Bilirubin | |
| Hemolysis: Interference less than 3% up to | Hemolysis: Interference less than 10% up to | |
| 500 mg/dL Hemolysate | ||
| Lipemia: Interference less than 10% up to | 500 mg/dL Hemolysate | |
| 300 mg/dL Intralipid | Lipemia: Interference less than 10% up to | |
| 400 mg/dL Intralipid | ||
| Not Tested | Ascorbic Acid: Interference less than 1% up | |
| to 20 mg/dL Ascorbate | ||
| AU2700/5400 | AU2700/5400 | |
| Bilirubin: Interference less than 8% up to | ||
| 40 mg/dL Bilirubin | Bilirubin: Interference less than 10% up to | |
| Hemolysis: Interference less than 3% up to | 40 mg/dL Bilirubin | |
| Hemolysis: Interference less than 5% up to | ||
| 500 mg/dL Hemolysate | 500 mg/dL Hemolysate | |
| Lipemia: Interference less than 10% up to | Lipemia: İnterference less than 10% up to | |
| 200 mg/dL. Intralipid | 400 mg/dL Intralipid | |
| Not Tested | Ascorbic Acid: Interference less than 3% up | |
| Function Sensitivity |