(23 days)
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No
The device description and intended use clearly define it as a liquid calibrator for clinical chemistry assays, with no mention of AI or ML technologies.
No
Explanation: This device is a calibrator for in-vitro diagnostic assays, used to establish reference points for measuring specific proteins in human serum and plasma. It is not intended for the treatment, diagnosis, or prevention of disease in a patient.
No
Explanation: The device is described as a "calibrator prepared from plasmatic plasmaproteins" for use in "to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid 1 - Antitrypsin, Glycoprotein, Alpha Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma." Its function is calibration of other tests, not diagnosis itself.
No
The device description clearly states it is a liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum, consisting of bottles of aqueous material. This describes a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of..." These are all substances measured in vitro (outside the body) in human samples (serum and plasma).
- Device Description: It describes a "liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum." Calibrators are essential components of many in vitro diagnostic tests.
- Method: It specifies use with "immunoturbidimetric methods," which are common techniques used in in vitro diagnostic assays.
- Sample Type: The device is used with "human serum and plasma," which are biological samples analyzed in vitro.
The core function of this device is to provide a reference standard for in vitro tests performed on human biological samples to diagnose or monitor medical conditions. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sentinel Plasmaproteins Cal 3x must only be used for the calibration of plasmaprotein tests with the immunoturbidimetric methods.
Clinical Chemistry - The Sentinel Plasmaproteins Cal 3x is a device intended for medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid 1 - Antitrypsin, Glycoprotein, Alpha Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The Sentinel Plasmaproteins Cal 3x is a liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum. It consists of 4 x 1 mL bottles of aqueous material containing Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in a human serum matrix. This material, when stored as directed, is stable until the date printed on the label. Calibrator traceability was stated as certificated to CRM 470 (Certified Reference Material), renamed ERM-DA 470 (European Reference Materials).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
The modified Plasmaproteins Cal 3x is substantially equivalent to the Predicate Device and to the previous Cleared Plasmaproteins Cal 3x as demonstrated by results obtained in the studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 § 862.9.
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JUN 2 5 2008
510(k) Summary
Submitter's Name/Address SENTINEL CH. SpA Via Robert Koch, 2
20152 Milano - Italy
Contact Person Fabio Rota Technical Director Regulatory Affairs Tel. +39 02 34551448 Fax: +39 02 34551464
| Date of Preparation of this Summary: | May 30Th, 2008 |
|---|---|
| Device Trade or Proprietary Name: | Sentinel Plasmaproteins Cal 3X |
| Device Common/Usual Name or | |
| Classification Name: | Plasmaproteins Cal 3X |
| Classification Number/Class: | JIX/Class II |
This summary of 510(k) safety and cffectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1
Device Description:
Original (Plasmaproteins Cal 3x, K051457).
The Sentinel Plasmaproteins Cal 3x is a liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum. It consists of 4 x 1 mL bottles of aqueous material containing Ceruloplasmin, Kappa light chains and Lambda light chains in a human serum matrix. This material, when stored as directed, is stable until the date printed on the label. Calibrator traceability was stated as certificated to CRM 470 (Certified Reference Material).
Modified Plasmaproteins Cal 3x
The Sentinel Plasmaproteins Cal 3x is a liquid, ready-to-use calibrator prepared from plasmatic plasmaproteins in human-based serum. It consists of 4 x 1 mL bottles of aqueous material containing Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in a human serum matrix. This material, when stored as directed, is stable until the date printed on the label. Calibrator traceability was stated as certificated to CRM 470 (Certified Reference Material), renamed ERM-DA 470 (European Reference Materials).
2
Description of modifications:
The modified Plasmaproteins Cal 3x is substantially equivalent to the previous cleared Sentinel Plasmaproteins 3x (K051457) and to the predicate device Roche Calibrator for Automated Systems (C.f.a.s.) Proteins (K011226).
The modification with respect to K051457 consists of certification in the following new analytes:
- Alpha 1-Acid Glycoprotein a )
- b) Alpha 1-Antitrypsin
- c) Haptoglobin
- d) Immunoglobulin A
- Immunoglobulin G c)
- f) Immunoglobulin M
- Transferrin g)
All the above listed analytes arc already contained in the original Plasmaproteins Cal 3x. Thus neither modification of the chemical's compositions nor of its production procedures have been made to the original Plasmaproteins Cal 3x (K051457).
These modifications did not significantly change the safety and effectiveness of the device as demonstrated in the Performance Characteristics Summary.
3
Intended Use:
Sentinel Plasmaproteins Cal 3x must only be used for the calibration of plasmaprotein tests with the immunoturbidimetric methods.
Description of the Calibrator Material:
Sentinel Plasmaproteins Cal 3x contains analytes (plasmaproteins) in human serum based matrix. The analytes consist of:
- Alpha 1-Acid Glycoprotein દા )
- Alpha 1-Antitrypsin b)
- ে) Haptoglobin
- Immunoglobulin A d)
- e) Immunoglobulin G
- f) Immunoglobulin M
- Transferrin பூ)
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Assigned Values and Value Assignment Process:
Target value assignment procedure is described in internal SOP and under defined conditions.
Immunoturbidimetric assays are calibrated against an Internal Calibrator Master Lot on a specific automatic analyzer as shown in the table below:
| Analyte/assays | Instrument |
|---|---|
| Alpha 1-Acid Glycoprotein | Roche Hitachi 911 |
| Alpha 1-Antitrypsin | Roche Hitachi 911 |
| Ceruloplasmin | Abbott c8000 ARCHITECT® |
| Haptoglobin | Roche Hitachi 911 |
| Immunoglobulin A | Roche Hitachi 911 |
| Immunoglobulin G | Roche Hitachi 911 |
| Immunoglobulin M | Roche Hitachi 911 |
| Kappa | Abbott c8000 ARCHITECT® |
| Lambda | Abbott c8000 ARCHITECT® |
| Transferrin | Roche Hitachi 911 |
During each testing run the following samples are tested:
- Two levels (normal and abnormal) of approved control materials in 1. triplicate to cnsure the effectiveness of the measurements.
-
- Aliquots of Internal Calibrator Master lot in triplicate
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- Aliquots of Plasmaproteins Cal 3x to be tested in triplicate
For each analyte, three (3) analytical runs on at least two (2) different days are performed.
Single run is accepted if:
The results of level normal and abnormal approved control materials are within 1. the expected ranges.
-
- The % recovery of Internal Calibrator Master Lot is within 97% - 103%.
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The mean and Standard Deviation and %CV of the all measurements are calculated. Data is inspected for outliers detection (single data-Mean > 3SD) and for imprecision of the measurements according to predefined criteria.
In case of abscncc of outliers and of imprecision >= 5 %, the obtained mean is the Target value.
The obtained Target value has to be within the range indicated in the following table:
| Analyte | Plasmaproteins 3x (mg/dL) |
|---|---|
| alpha 1-Acid Glycoprotein | From 176 to 254 |
| Albumin | From 9344 to 14016 |
| Alpha 1-Antitrypsin | From 334 to 454 |
| Ceruloplasmin | From 66 to 124 |
| Haptoglobin | From 272 to 366 |
| Immunoglobulin A | From 478 to 718 |
| Immunoglobulin G | From 2264 to 3396 |
| Immunoglobulin M | From 204 to 3396 |
| Kappa | From 508 to 762 |
| Lambda | From 306 to 458 |
| Transferrin | From 580 to 872 |
Directions for Use:
Refer to Draft Package Insert and Draft Labelling on Section IV and Section V.
Performance Characteristics:
Please refer to Section III.
Conclusion:
The modified Plasmaproteins Cal 3x is substantially equivalent to the Predicate Device and to the previous Cleared Plasmaproteins Cal 3x as demonstrated by results obtained in the studies.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 5 2008
Sentinel CH. SPA c/o Mr. Fabio Rota via Robert Koch, 2 Milano, Italy 20152
Re: K081533
Trade/Device Name: Sentinel Plasmaproteins Cal 3x Regulation Number: 21 CFR 862.1150 Regulation Name: Claibrator Regulatory Class: Class II Product Code: JIX Dated: May 30, 2008 Received: June 02, 2008
Dear Mr. Rota:
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 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).
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Page 2 -
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.
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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Plasmaproteins Cal 3x
Indications for Use
Clinical Chemistry - The Sentinel Plasmaproteins Cal 3x is a device intended for medical purposes for use in Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid Glycoprotein, Alpha 1-Antitrypsin, Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M assays, to establish points of reference that are used in the determination of values in the measurement of Ceruloplasmin, Kappa light chains, Lambda light chains, Transferrin, Alpha 1-Acid 1 - Antitrypsin, Glycoprotein, Alpha Haptoglobin, Immunoglobulin A, Immunoglobulin G and Immunoglobulin M in human serum and plasma.
Prescription Use_X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
e of In Vitro Diagn
510(k) K081533