(222 days)
OUIEG09E0504
No
The device description and performance studies focus on a standard turbidimetric immunoassay method for measuring Ceruloplasmin. There is no mention of AI or ML in the description, intended use, or performance evaluation.
No.
The device is for the quantitative determination of Ceruloplasmin to aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "as an aid in the diagnosis of copper metabolism disorders."
No
The device is a reagent kit, which is a physical chemical substance used in laboratory tests, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma... as an aid in the diagnosis of copper metabolism disorders." This clearly indicates the device is used to examine specimens derived from the human body (serum and plasma) to provide information for diagnostic purposes.
- Device Description: The description details a "reagent kit" used in a "turbidimetric method" on "Beckman Coulter AU analyzers." This describes a laboratory test system used to analyze biological samples.
- Performance Studies: The summary of performance studies describes experiments like "Method comparison," "Precision," "Linearity," and "Interferences," which are standard evaluations for in vitro diagnostic devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K053074) and name ("N Antisera to Human Ceruloplasmin") is a strong indicator that this device is being submitted for regulatory review as an IVD, comparing it to a previously cleared IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.
Product codes
DDB
Device Description
The Ceruloplasmin reagent kit is in a liquid, ready to use form. It is available in one format OSR6164 which consists of 4 x 18mL R1 vials and 4 x 5ml R2 vials. The calibrator is a Beckman Coulter Serum protein multi-calibrator ODR3023 which is sold separately. Ceruloplasmin is a turbidimetric method the basis for this method is the measurement of the decrease in light transmitted (increase in absorbance) through the particles suspended in solution as a result of complexes formed during the antigen-antibody reaction.
The Ceruloplasmin reagent is designed for optimal performance on the Beckman Coulter AU analyzers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum and plasma
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
Method comparison, Precision, Linearity, Sensitivity, Interferences, Stability and Expected Values, Prozone (Hook effect) and Auto-dilution.
Method Comparison Study Results:
Reference: Siemens (OUIEG09E0504)
Test: Ceruloplasmin (OSR6x64)
Sample Range: Ref: 108 mg/L- 1890 mg/L; Test: 98 mg/L - 1880 mg/L
Specifications: Slope: 0.900-1.100, Intercept: ≤ ± 30mg/L, r: ≥0.975, N:≥100
Results: Slope: 1.056, Intercept: -26.10mg/L, r: 0.990, N: 120
Pass/Fail: Pass
Precision Study Results:
| Sample | Concentration mg/L | Within Run Precision %CV | Within Run Precision SD | Within Run Precision Specification | Total Precision %CV | Total Precision SD | Total Precision Specification | Pass/Fail |
|---|---|---|---|---|---|---|---|---|
| Pool 1 | 95.99 | 1.10 | 1.042 | ≤5% CV or SD ≤1 mg/dL (10mg/L) | 6.7 | 6.44 | ≤10% CV or SD ≤2 mg/dL (20mg/L) | Pass |
| Pool 2 | 148.36 | 1.10 | 1.70 | ≤5% CV or SD ≤1 mg/dL (10mg/L) | 2.80 | 4.09 | ≤10% CV or SD ≤2 mg/dL (20mg/L) | Pass |
| Pool 3 | 254.17 | 0.90 | 2.30 | ≤5% CV or SD ≤1 mg/dL (10mg/L) | 2.20 | 5.70 | ≤10% CV or SD ≤2 mg/dL (20mg/L) | Pass |
| Pool 4 | 596.43 | 0.90 | 5.46 | ≤5% CV or SD ≤1 mg/dL (10mg/L) | 1.90 | 11.36 | ≤10% CV or SD ≤2 mg/dL (20mg/L) | Pass |
| Pool 5 | 915.61 | 0.7 | 6.78 | ≤5% CV or SD ≤1 mg/dL (10mg/L) | 1.6 | 14.51 | ≤10% CV or SD ≤2 mg/dL (20mg/L) | Pass |
| Pool 6 | 1791.94 | 0.5 | 9.52 | ≤5% CV or SD ≤1 mg/dL (10mg/L) | 1.4 | 25.23 | ≤10% CV or SD ≤2 mg/dL (20mg/L) | Pass |
Key Metrics
Sensitivity: ≤6mg/dL (60mg/L).
Linearity Range: 60 - 2000 mg/L
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5210 Ceruloplasmin immunological test system.
(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2016
Beckman Coulter Ireland Inc. Ms. Marguerita Sweeney Regulatory Affairs Manager Lismeehan, O'Callaghan's, Mills CO. Clare, Ireland
Re: K161508
Trade/Device Name: Ceruloplasmin Regulation Number: 21 CFR 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: II Product Code: DDB Dated: November 28, 2016 Received: December 8, 2016
Dear Ms. Sweeney:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161508
Device Name Ceruloplasmin
Indications for Use (Describe)
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary Ceruloplasmin Reagent
1.0
Submitted By:
Marguerita Sweeney Regulatory Affairs Manager Beckman Coulter Ireland, Inc. Lismeehan, O'Callaghan's Mills Co. Clare, Ireland Telephone: +353-65-683-1495 Fax: +353-65-683-1122 Email: msweeney@beckman.com
2.0 Date of preparation:
May 26th 2016
3.0 Device Identification:
Proprietary Names: Ceruloplasmin Common Name: Ceruloplasmin Classification: 866.5210 Product Code: DDB
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket Number |
|---|---|---|---|
| Ceruloplasmin | N Antisera to Human | ||
| Ceruloplasmin | Siemens (formerly | ||
| Dade-Behring) | K053074 |
The Ceruloplasmin reagent is substantially equivalent to the product listed above currently in commercial distribution
5.0 Description:
The Ceruloplasmin reagent kit is in a liquid, ready to use form. It is available in one format OSR6164 which consists of 4 x 18mL R1 vials and 4 x 5ml R2 vials. The calibrator is a Beckman Coulter Serum protein multi-calibrator ODR3023 which is sold separately. Ceruloplasmin is a turbidimetric method the basis for this method is the measurement of the decrease in light transmitted (increase in absorbance) through the particles suspended in solution as a result of complexes formed during the antigen-antibody reaction.
The Ceruloplasmin reagent is designed for optimal performance on the Beckman Coulter AU analyzers.
4
6.0 Intended Use:
System reagent for the quantitative determination of Ceruloplasmin (CER) in human serum and plasma on Beckman Coulter AU analyzers as an aid in the diagnosis of copper metabolism disorders.
Clinical Significance
Ceruloplasmin's main clinical importance is in the diagnosis of Wilson's disease. Increased levels of Ceruloplasmin are particularly notable in diseases of the reticuloendothelial system such as Hodgkin's disease and also during pregnancy or use of contraceptive pills. Low levels of ceruloplasmin are found in malnutrition, malabsorption, nephrosis and severe liver disease particularly biliary cirrhosis.
7.0 Comparison to Predicate(s):
The following tables shows similarities and differences between the predicate identified in Section 4.0 of this summary.
| Similarities | ||
|---|---|---|
| Feature | Ceruloplasmin reagent | Predicate |
| Intended Use | System reagent for the | |
| quantitative determination of | ||
| Ceruloplasmin (CER) in human | ||
| serum and plasma on Beckman | ||
| Coulter AU analyzers as an aid in | ||
| the diagnosis of copper | ||
| metabolism disorders. | In-vitro diagnostic reagents for the | |
| quantitative determination of | ||
| ceruloplasmin and hemopexin in | ||
| human serum and heparanised | ||
| plasma by means of | ||
| immunonephelopetry on the BN II | ||
| and BN Prospec ® system. | ||
| Measurement | Quantitative | Quantitative |
| Reagent | Liquid, Ready to use | Liquid, Ready to use |
| Calibration | Serum Protein Multi-calibrator | |
| (ODR3023) which is traceable to | ||
| IFCC CRM470 | N Protein Standard | |
| (OQIMG13E0502) which is | ||
| traceable to ERM470 | ||
| Reagent | ||
| Storage/Closed | ||
| Shelf Life | 2-8°C until expiration date | 2-8°C until expiration date |
| Linearity Range | 60 - 2000 mg/L | Ceruloplasmin: |
| 0.07 - 2.2 g/L for a sample dilution | ||
| of 1:20. | ||
| Composition | Rabbit anti-human Ceruloplasmin | |
| antiserum | ||
| Solution of polymers in Tris | ||
| buffer (pH 7.4-7.6) | ||
| Preservatives - Sodium Azide & | Rabbit anti-human Ceruloplasmin | |
| antiserum | ||
| Preservatives - Sodium Azide |
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| Gentamicin | ||
|---|---|---|
| Specimen Type | Serum and Plasma (Sodium | |
| Heparin and Lithium Heparin) | Serum and heparinized plasma | |
| Expected Values | 200 - 600 mg/L | Ceruloplasmin: 0.2-0.6g/L (200- |
| 600mg/L | ||
| Hemopexin: 0.5 - 1.15g/L (500- | ||
| 1150mg/L) |
| Differences | ||
|---|---|---|
| Feature | Ceruloplasmin reagent | Predicate |
| Assay Methodology/ | ||
| Operating principle | Immunoturbitimetric | Immunonephelometry |
| Instrumentation | Beckman Coulter AU Clinical | |
| Chemistry analyzers | Siemens BN II and BN Prospec | |
| ® Systems | ||
| Reagent On-board | ||
| Stability | 90 days | 3 days |
| Calibration Frequency | 14 days | Not specified |
| Interfering Substances | Bilirubin: | |
| No significant interference | ||
| (≤10%) up to 40mg/dL | Bilirubin: | |
| No interference up to 0.6g/L | ||
| Hemolysis: | ||
| No significant interference | ||
| (≤10%) up to 500 mg/dL | Hemolysis: | |
| No interference up to 10g/L | ||
| Triglyceride: | ||
| No significant interference | ||
| (≤10%) up to 1000mg/dL | Triglyceride: | |
| No interference up to 2.4g/L | ||
| Rheumatoid Factor (RF): | ||
| No significant interference | ||
| (≤10%) up to 500 IU/mL | ||
| Sensitivity | ≤6mg/dL (60mg/L) | Established by lower limit of |
| reference curve - depends on | ||
| the concentration of proteins in | ||
| the N protein standard SL |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to a predicate chemistry test systems already in commercial distribution. Equivalence is demonstrated through performance characteristics testing. Experiments included: Method comparison, Precision, Linearity, Sensitivity, Interferences, Stability and Expected Values, Prozone (Hook effect) and Auto-dilution.
Performance on method comparison and precision are summarized below:
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Method Comparison Study Results
| Reference | Test | Sample
Range: | Specifications | Results | Pass/Fail |
|---------------------------|----------------------------|-------------------------------------------------------------------|--------------------------|--------------------------|-----------|
| Siemens
(OUIEG09E0504) | Ceruloplasmin
(OSR6x64) | Ref:
108 mg/L-
1890 mg/L
Test:
98 mg/L -
1880 mg/L | Slope:
0.900-1.100 | Slope:
1.056 | Pass |
| | | | Intercept:
≤ ± 30mg/L | Intercept:
-26.10mg/L | Pass |
| | | | r: ≥0.975 | 0.990 | Pass |
| | | | N:≥100 | 120 | Pass |
Precision Study Results
| Sample | Concentration
mg/L | Within Run Precision | | | Total Precision | | | Pass/
Fail |
|--------|-----------------------|----------------------|-------|--------------------------------------|-----------------|-------|---------------------------------------|---------------|
| | | %CV | SD | Specification | %CV | SD | Specification | |
| Pool 1 | 95.99 | 1.10 | 1.042 | ≤5% CV or
SD ≤1 mg/dL
(10mg/L) | 6.7 | 6.44 | ≤10% CV or
SD ≤2 mg/dL
(20mg/L) | Pass |
| Pool 2 | 148.36 | 1.10 | 1.70 | ≤5% CV or
SD ≤1 mg/dL
(10mg/L) | 2.80 | 4.09 | ≤10% CV or
SD ≤2 mg/dL
(20mg/L) | Pass |
| Pool 3 | 254.17 | 0.90 | 2.30 | ≤5% CV or
SD ≤1 mg/dL
(10mg/L) | 2.20 | 5.70 | ≤10% CV or
SD ≤2 mg/dL
(20mg/L) | Pass |
| Pool 4 | 596.43 | 0.90 | 5.46 | ≤5% CV or
SD ≤1 mg/dL
(10mg/L) | 1.90 | 11.36 | ≤10% CV or
SD ≤2 mg/dL
(20mg/L) | Pass |
| Pool 5 | 915.61 | 0.7 | 6.78 | ≤5% CV or
SD ≤1 mg/dL
(10mg/L) | 1.6 | 14.51 | ≤10% CV or
SD ≤2 mg/dL
(20mg/L) | Pass |
| Pool 6 | 1791.94 | 0.5 | 9.52 | ≤5% CV or
SD ≤1 mg/dL
(10mg/L) | 1.4 | 25.23 | ≤10% CV or
SD ≤2 mg/dL
(20mg/L) | Pass |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92