(61 days)
Not Found
No
The device description details a turbidimetric immunoassay based on antigen-antibody reactions and light scattering measurements, which is a standard laboratory technique and does not involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an in vitro diagnostic (IVD) reagent used to measure IgG levels in human samples, aiding in diagnosis rather than providing direct therapy.
Yes
The device is described as "System reagent for the quantitative determination of IgG immunoglobulins... The measurement of IgG aids in the diagnosis of abnormal protein metabolism...For in vitro diagnostic use." This explicitly states its purpose is to aid in diagnosis.
No
The device description clearly outlines a system reagent and its interaction with human samples on OLYMPUS analyzers, involving chemical reactions and turbidimetry measurements. This indicates a physical reagent and hardware components (the analyzer), not a software-only device.
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."
- Intended Use: The device is intended for the "quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid." This is a diagnostic measurement performed on biological samples in vitro (outside the body).
- Diagnostic Purpose: The measurement of IgG is stated to "aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This directly relates to providing information for diagnostic purposes.
- Device Description: The description details a laboratory procedure involving the reaction of a sample with reagents to form immune complexes, which are then measured using turbidimetry. This is a typical in vitro diagnostic method.
N/A
Intended Use / Indications for Use
System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers.
The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
CFN
Device Description
In this Olympus procedure:
- When a sample is mixed with R1 buffer and R2 antiserum solution, human IgG reacts specifically with anti-human IgG 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Similarities and Differences sections compare the new Olympus IgG (OSR6X172) reagent with predicate devices for Serum/Plasma Applications and CSF Application.
Serum/Plasma Applications:
Similarities:
- Measurement: Quantitative
- Instrument Required: Olympus AU400/400e, 600/640/640e and 2700/5400
- Reagent handling: Ready for use
- Assay Methodology/Operating Principle: Immunoturbidimetric
- Reagent storage form: Liquid, On-board storage
- Calibration: Olympus Serum Protein Multi-Calibrator (ODR3021)
- Calibration Traceability: This method is traceable to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619)
- Antibody: Goat Anti-IgG antiserum
- Expected Values: 635-1741 mg/dL
- Reagent On Board Stability: Opened reagents are stable for 90 days when stored in the refrigerated compartment of the analyzer.
- Calibration Frequency: 90 days
Differences:
- Specimen Type: Serum, Li-heparin or EDTA plasma: and cerebrospinal fluid (Predicate: Serum)
- LoQ: 75 mg/dL (Predicate: Not specified)
- Prozone Capacity: No high dose effect at IgG concentrations up to 30,000 mg/dL (Predicate: Not specified)
Precision (Sample Total CV%):
AU400/400e: Sample 1: 2.18, Sample 2: 2.29, Sample 3: 3.43 (Predicate: Sample 1: 0.82, Sample 2: 1.06, Sample 3: 2.24)
AU600/640/640e: Sample 1: 3.29, Sample 2: 3.49, Sample 3: 4.66
AU640/640e: Sample 1: 1.00, Sample 2: 1.00
AU2700/5400: Sample 1: 1.54, Sample 2: 2.39, Sample 3: 2.84 AND Sample 1: 1.51, Sample 2: 1.87, Sample 3: 2.03 (Predicate AU2700/5400: Sample 1: 1.54, 2.39, 2.84, Sample 1: 2.50, Sample 2: 1.54, Sample 3: 1.92)
Method Comparison (Linear Regression):
Intercept: 37.2 (Predicate: -117)
Slope: 0.945 (Predicate: 1.086)
R2: 0.998 (Predicate: 0.993)
n: 120 (Predicate: 98)
Range: 195-2986 mg/dL (Predicate: 223-2633 mg/dL)
Interfering Substances:
AU400/400e:
Bilirubin: Interference less than 2% up to 40 mg/dL Bilirubin
Hemolysate: Interference less than 3% up to 500 mg/dL Hemolysate
Lipemia: Interference less than 3% up to 1000 mg/dL Intralipid
RF: Interferences less than 7% up to 1200 IU/mL
Not tested
AU600/640/640e:
Bilirubin: Interference less than 3% up to 40 mg/dL Bilirubin
Hemolysate: Interference less than 3% up to 500 mg/dL Hemolysate
Lipemia: Interference less than 5% up to 1000 mg/dL Intralipid
RF: Interferences less than 7% up to 1200 IU/mL
Not tested
AU2700/5400:
Bilirubin: Interference less than 1% up to 40 mg/dL Bilirubin
Hemolysate: Interference less than 3% up to 500 mg/dL Hemolysate
Lipemia: Interference less than 2% up to 1000 mg/dL Intralipid
RF: Interferences less than 7% up to 1200 IU/mL
Not tested
CSF Application:
Similarities:
- Measurement: Quantitative
- Specimen Type: Serum, plasma: Li-heparin or EDTA and cerebrospinal fluid
- Antibody: Goat Anti-IgG antiserum
- Reagent handling: Ready for use
- Assay Methodology/Operating Principle: Immunoturbidimetric
- Reagent storage form: Liquid, On-board storage
- Calibration Traceability: CRM 470
- Calibration: Multi-point
Differences:
- Instrument Required: Olympus AU400/400e, 600/640/640e and 2700/5400 (Predicate: Roche/Hitachi Cobas c systems)
- Expected Values: 15 – 20 y 3.5 mg/dL ± 2.0 mg/dL, 21 – 40 y 4.2 mg/dL ± 1.4 mg/dL, 41 – 60 y 4.7 mg/dL ± 1.0 mg/dL (Predicate: 1-3 mg/dL)
- Reagent On Board Stability: Opened reagents are stable for 90 days when stored in the refrigerated compartment of the analyzer. (Predicate: Opened reagents are stable for 84 days when stored in the refrigerated compartment of the analyzer.)
- Calibration: Olympus Serum Protein Mulit-Calibrator (ODR3021) (Predicate: S1 H₂O, S2 C.f.a.s. PUC)
- Calibration Frequency: 2 Days (Predicate: Not Specified)
Performance Characteristics:
- Assay Range: 2-50 mg/dL (Predicate: 0.4-20 mg/dL)
- LoQ: 2 mg/dL (Predicate: Not specified)
- Prozone Capacity: No high dose effect at IgG concentrations up to 6,000 mg/dL (Predicate: No high dose effect at IgG concentrations up to 100 mg/dL)
Precision (Total CV%):
AU400/400e: Sample 1: 9.82, Sample 2: 4.08, Sample 3: 3.61
AU600/640/640e: Sample 1: 9.53, Sample 2: 3.67, Sample 3: 2.81
AU2700/5400: Sample 1: 10.24, Sample 2: 6.29, Sample 3: 3.83 (Predicate Sample 1: 2.1, Sample 2: 1.1)
Method Comparison (Linear Regression):
Intercept: -0.069 (Predicate: -0.17)
Slope: 1.067 (Predicate: 0.997)
R2: 0.998 (Predicate: 1.000)
Range: 2.0-42.9 mg/dL (Predicate: 1.07-18.6 mg/dL)
Interfering Substances:
AU400/400e/600/640/640e/2700/5400:
Bilirubin: Interference less than 10% up to 36 mg/dL Bilirubin
Hemolysis: Interference less than 10% up to 500 mg/dL Hemolysate (Predicate: Bilirubin: Interference less than 10% up to 15 mg/dL Bilirubin, Hemolysis: Interference less than 10% up to 200 mg/dL Hemolysate)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
The assigned 510(k) number is: 3073490
| 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 10, 2007 |
| 2. Device name | |
| Proprietary Name: | Olympus IgG Reagent (OSR6X172) |
| Common Name: | IgG Reagent |
| Classification Name: | IgG, Antigen, Antiserum, Control |
| 3. Predicate device(s) | |
| Serum/Plasma Applications | Olympus (OSR6145) IgG Reagent
Submitted (K951013) |
| CSF Application | Roche Tina-Quant IgG GEN.2
Submitted (K050113) |
| 4. Device description | In this Olympus procedure:
When a sample is mixed with R1 buffer and R2 antiserum solution, human IgG reacts specifically with anti-human IgG 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 IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers.
For in vitro diagnostic use. |
1
The following tables compare the new Olympus IgG (OSR6X172)
reagent with the predicate devices outlined in point 3 above.
Serum/Plasma Applications
| Similarities | ||
|---|---|---|
| Item | Olympus IgG (OSR6X172) reagent | Predicate System |
| Intended Use | System reagent for the quantitative | |
| determination of IgG immunoglobulins | ||
| in human serum, plasma and | ||
| cerebrospinal fluid on OLYMPUS | ||
| analyzers. | System reagent for the quantitative | |
| determination of IgG immunoglobulins | ||
| in human serum on OLYMPUS | ||
| analyzers. | ||
| Measurement | Quantitative | Same |
| Instrument Required | Olympus AU400/400°, 600/640/640° | |
| and 2700/5400 | Same | |
| Reagent handling | Ready for use | Same |
| Assay | ||
| Methodology/Operating | ||
| Principle | Immunoturbidimetric | Same |
| Reagent storage form | Liquid | |
| On-board storage | Same | |
| Calibration | Olympus Serum Protein Multi- | |
| Calibrator (ODR3021) | Same | |
| Calibration Traceability | This method is traceable to the | |
| International Reference Preparation CRM | ||
| 470 (US designation RPPHS lot 91/0619) | Same | |
| Antibody | Goat Anti-IgG antiserum | Same |
| Expected Values | 635-1741 mg/dL | Same |
| Reagent On Board Stability | Opened reagents are stable for 90 | |
| days when stored in the refrigerated | ||
| compartment of the analyzer. | Same | |
| Calibration Frequency | 90 days | Same |
| Differences | Item | Olympus IgG (OSR6X172) reagent | Predicate System | ||
|---|---|---|---|---|---|
| Item | Olympus IgG (OSR6X172) reagent | Predicate System | Assay Range | 75-3000 mg/dL | 75-3000 mg/dL |
| Specimen Type | Serum, Li-heparin or EDTA plasma: | ||||
| and cerebrospinal fluid | Serum | LoQ | 75 mg/dL | Not specified | |
| Prozone Capacity | No high dose effect at IgG concentrations up to 30,000 mg/dL | Not specified | |||
| Precision | AU400/400e | ||||
| Sample Total CV% | |||||
| 1 2.18 | |||||
| 2 2.29 | |||||
| 3 3.43 |
AU600/640/640e
Sample Total CV%
1 3.29
2 3.49
3 4.66 | AU400/400e
Sample Total CV%
1 0.82
2 1.06
3 2.24
AU600
Sample Total CV%
1 2.50
2 1.54
3 1.92 | | | |
| | AU640/640°
Sample
1
2 | Total CV%
1.00
1.00 | AU2700/5400
Sample
1
2
3 | Total CV%
1.54
2.39
2.84 | |
| | AU2700/5400
Sample
1
2
3 | Total CV%
1.51
1.87
2.03 | | | |
| Method Comparison (Linear Regression) | Intercept
Slope
R2
n
Range | 37.2
0.945
0.998
120
195-2986 mg/dL | Intercept
Slope
R2
n
Range | -117
1.086
0.993
98
223-2633 mg/dL | |
| Interfering Substances | AU400/400°
Bilirubin: Interference less than 2% up
to 40 mg/dL Bilirubin
Hemolysate: Interference less than 3%
up to 500 mg/dL Hemolysate
Lipemia: Interference less than 3% up
to 1000 mg/dL Intralipid
RF: Interferences less than 7% up to
1200 IU/mL
Not tested
AU600/640/640°
Bilirubin: Interference less than 3% up
to 40 mg/dL Bilirubin
Hemolysate: Interference less than 3%
up to 500 mg/dL Hemolysate
Lipemia: Interference less than 5% up
to 1000 mg/dL Intralipid
RF: Interferences less than 7% up to
1200 IU/mL
Not tested
AU2700/5400
Bilirubin: Interference less than 1% up
to 40 mg/dL Bilirubin
Hemolysate: Interference less than 3%
up to 500 mg/dL Hemolysate
Lipemia: Interference less than 2% up
to 1000 mg/dL Intralipid
RF: Interferences less than 7% up to
1200 IU/mL
Not tested | AU400/400°
Bilirubin: Interference less than 1% up
to 40 mg/dL Bilirubin
Hemolysis: Interference less than 2%
up to 500 mg/dL Hemolysate
Lipemia: Interference less than/10% up
to 1000 mg/dL Intralipid.
RF: Not Specified
Ascorbic acid: Interference less than
1% up to 20 mg/dL Ascorbate
AU600/640/640°
Bilirubin: Interference less than 2% up
to 40 mg/dL Bilirubin
Hemolysis: Interference less than 2%
up to 500 mg/dL Hemolysate
Lipemia: Interference less than 3% up
to 1000 mg/dL Intralipid.
RF: Not Specified
Ascorbic acid: Interference less than
2% up to 20 mg/dL Ascorbate
AU2700/5400
Bilirubin: Interference less than 5% up
to 40 mg/dL Bilirubin
Hemolysis: Interference less than 3%
up to 500 mg/dL Hemolysate
Lipemia: Interference less than 3% up
to 1000 mg/dL Intralipid.
RF: Not Specified
Ascorbic acid: Interference less than
3% up to 20 mg/dL Ascorbate | | | |
ნ.
2
3
CSF Application
| Similarities | ||
|---|---|---|
| Item | Olympus IgG (OSR6X172) reagent | Predicate Systems |
| Intended Use | System reagent for the quantitative | |
| determination of IgG immunoglobulins | ||
| in human serum, plasma and | ||
| cerebrospinal fluid on OLYMPUS | ||
| analyzers. | In vitro test for the quantitative determination | |
| of IgG in human serum, plasma and | ||
| cerebrospinal on Roche/Hitachi Cobas c | ||
| systems. | ||
| Measurement | Quantitative | Same |
| Specimen Type | Serum, plasma: Li-heparin or EDTA | |
| and cerebrospinal fluid | Same | |
| Antibody | Goat Anti-IgG antiserum | Same |
| Reagent handling | Ready for use | Same |
| Assay | ||
| Methodology/Operating | ||
| Principle | Immunoturbidimetric | Same |
| Reagent storage form | Liquid | |
| On -board storage | Same | |
| Calibration Traceability | CRM 470 | Same |
| Calibration | Multi-point | Same |
| Differences | ||
|---|---|---|
| Item | Olympus IgG (OSR6X172) reagent | Predicate System |
| Instrument Required | Olympus AU400/400°, 600/640/640° | |
| and 2700/5400 | Roche/Hitachi Cobas c systems. | |
| Expected Values | 15 – 20 y 3.5 mg/dL ± 2.0 mg/dL. | |
| 21 – 40 y 4.2 mg/dL ± 1.4 mg/dL. | ||
| 41 – 60 y 4.7 mg/dL ± 1.0 mg/dL | 1-3 mg/dL | |
| Reagent On Board Stability | Opened reagents are stable for 90 days | |
| when stored in the refrigerated | ||
| compartment of the analyzer. | Opened reagents are stable for 84 days | |
| when stored in the refrigerated compartment | ||
| of the analyzer. | ||
| Calibration | Olympus Serum Protein Mulit- | |
| Calibrator (ODR3021) | S1 H₂O | |
| S2 C.f.a.s. PUC | ||
| Calibration Frequency | 2 Days | Not Specified |
.
| Performance Characteristics | ||||
|---|---|---|---|---|
| Item | Olympus IgG (OSR6X172) reagent | Predicate System | ||
| Assay Range | 2-50 mg/dL | 0.4-20 mg/dL | ||
| LoQ | 2 mg/dL | Not specified | ||
| Prozone Capacity | No high dose effect at IgG | |||
| concentrations up to 6,000 mg/dL | No high dose effect at IgG concentrations up | |||
| to 100 mg/dL | ||||
| Precision | AU400/400 e | |||
| Sample | ||||
| 1 | ||||
| 2 | ||||
| 3 | ||||
| AU600/640/640e | ||||
| Sample | ||||
| 1 | ||||
| 2 | ||||
| 3 | ||||
| AU2700/5400 | ||||
| Sample | ||||
| 1 | ||||
| 2 | ||||
| 3 | Total CV% | |||
| 9.82 | ||||
| 4.08 | ||||
| 3.61 | ||||
| Total CV% | ||||
| 9.53 | ||||
| 3.67 | ||||
| 2.81 | ||||
| Total CV% | ||||
| 10.24 | ||||
| 6.29 | ||||
| 3.83 | Sample | |||
| 1 | ||||
| 2 | Total CV% | |||
| 2.1 | ||||
| 1.1 |
4
| Intercept | -0.069 | Intercept | -0.17 | |
|---|---|---|---|---|
| Method Comparison (Linear | Slope | 1.067 | Slope | 0.997 |
| Regression) | R2 | 0.998 | R2 | 1.000 |
| Range | 2.0-42.9 mg/dL | Range | 1.07-18.6 mg/dL | |
| Interfering Substances | AU400/400e/600/640/640°/2700/5400 | |||
| Bilirubin: Interference less than 10% up | ||||
| to 36 mg/dL Bilirubin | ||||
| Hemolysis: Interference less than 10% | ||||
| up to 500 mg/dL Hemolysate | Bilirubin: Interference less than 10% up to | |||
| 15 mg/dL Bilirubin | ||||
| Hemolysis: Interference less than 10% up to | ||||
| 200 mg/dL Hemolysate |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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: K073490
Trade/Device Name: Olympus IgG 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
6
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. Becker
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
7
Indication for Use
510(k) Number (if known): KD73490
Device Name: The Olympus IgG reagent (OSR6X172).
Indication For Use: System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers.
The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.
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)
Mana M. Aan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073490