(60 days)
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No
The document describes a liquid calibrator for chemistry systems and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
This device is for in vitro diagnostic use, meaning it's used to calibrate laboratory systems for testing patient samples, not for direct therapeutic treatment.
No
This device is described as a "Calibrator" for in vitro diagnostic use, meaning it's used to calibrate a diagnostic system, not to perform a diagnosis itself. The text explicitly states it's "for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems."
No
The device is a liquid calibrator, which is a physical product containing biological materials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use..."
- Function: The device is a calibrator used to calibrate ADVIA Chemistry systems for various protein methods. Calibrators are essential components in in vitro diagnostic testing to ensure the accuracy of the measurements performed on patient samples.
- Context: The device description details its composition and how it is used within a laboratory setting for analyzing biological samples (implied by the protein analytes).
Therefore, based on the provided text, the ADVIA Chemistry Liquid Protein Calibrator is definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO 2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Immunoglobulin A 2 (IGA_2), Immunoglobulin G_2 (IGG_2), Immunoglobulin M 2 (IGM 2), Prealbumin (PREALB), Rheumatoid Factor (RF), Transferrin (TRF) methods
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid buffered based product containing multiple analytes (proteins derived from human source). The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required). The constituent concentrations of these Calibrators are present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL.
Anti-streptolysin-O (ASO), Alpha-1-Antitrypsin (AAT), Prealbumin (PREALB), Rheumatoid Factor (RF), Immunoglobulin A 2, (IGA 2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M 2 (IGM 2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Transferrin (TRF), and Alpha-Acid-Glycoprotein (AAG) are value assigned for ADVIA 1650 Chemistry systems.
In addition the calibrator also contains Ferritin and CRP with no specific value assignment on ADVIA Chemistry systems at this time.
Mentions image processing
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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)
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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.
0
510(k) Summary of Safety and Effectiveness for the
ADVIA® Chemistry Liquid Specific Protein Calibrators
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number: K10 370 /
B. Date of Preparation: December 03, 2010
C. Proprietary and Established Names:
ADVIA® Chemistry Liquid Specific Protein Calibrator
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Kira Gordon, Sr. Regulatory Affairs Specialist
Office: (914) 524-2996 Fax: (914) 524-2500
E. Regulatory Information:
ADVIA Chemistry Liquid Specific Protein Calibrator
-
- Regulation section: 21 CFR § 862.1150 Calibrator.
-
- Classification: Class II
-
- Product Code: JIX, calibrator, multi-analyte mixture
-
- Panel: Clinical Chemistry
F. Predicate Device:
Randox Liquid Protein Calibrators
ADVIA Chemistry Liquid Specific Protein Calibrator is substantially equivalent to the Randox Liquid Protein Calibrator cleared under K031608 and K061056.
G. Device Description:
ADVIA Chemistry Liquid Specific Protein Calibrator is a multi-analyte, liquid buffered based product containing multiple analytes (proteins derived from human source). The kit consists of 6 vials each of 6 calibrator levels which are ready for use (no preparation is required). The constituent concentrations of these Calibrators are
1
present at levels 2, 3, 4, 5 and 6. Level 1 is a zero level. The volume per vial is 1.0 mL.
Anti-streptolysin-O (ASO), Alpha-1-Antitrypsin (AAT), Prealbumin (PREALB), Rheumatoid Factor (RF), Immunoglobulin A 2, (IGA 2), Immunoglobulin G 2 (IGG 2), Immunoglobulin M 2 (IGM 2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Transferrin (TRF), and Alpha-Acid-Glycoprotein (AAG) are value assigned for ADVIA 1650 Chemistry systems.
In addition the calibrator also contains Ferritin and CRP with no specific value assignment on ADVIA Chemistry systems at this time.
H. Intended Use:
The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O 2 (ASO 2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Immunoglobulin A 2 (IGA_2), Immunoglobulin G_2 (IGG_2), Immunoglobulin M_2 (IGM_2), Prealbumin (PREALB), Rheumatoid Factor (RF), Transferrin (TRF) methods
I. Substantial Equivalence Information:
The ADVIA Chemistry Liquid Specific Protein Calibrator and Randox Liquid Protein Calibrator were compared in the following table.
| Item | New Device | Predicate Device (K061056 and K031608) |
|---|---|---|
| Intended Use | for in vitro diagnostic use in the calibration of | |
| ADVIA® Chemistry system for the Alpha- | ||
| Acid-Glycoprotein (AAG)*, Alpha-1- | ||
| Antitrypsin (AAT), Anti-streptolysin-O_2 | ||
| (ASO_2), Complement C3 (C3), Complement | ||
| C4 (C4), Haptoglobin (HAPT), Immunoglobulin | ||
| A_2 (IGA_2), Immunoglobulin G_2 (IGG_2), | ||
| Immunoglobulin M_2 (IGM_2), Prealbumin | ||
| (PREALB), Rheumatoid Factor (RF), | ||
| Transferrin (TRF) methods | K061056: | |
| for in vitro diagnostic use in the | ||
| calibration of ASO, Complement C3, | ||
| Complement C4, CRP, Ferritin, | ||
| Haptoglobin, IgA, IgG, IgM, Prealbumin, and | ||
| Transferrin assays on Clinical | ||
| Chemistry and Immunoassay systems | ||
| * - subject of this submission | K031608: | |
| for the calibration of ASO, Complement C3, | ||
| Complement C4, CRP, Ferritin, IgA, IgG, IgM, | ||
| Prealbumin and Transferrin assays (all neat | ||
| sample assays). These calibrators also contain a- | ||
| 1-Antitrypsin (AAT) and Rheumatoid Factor | ||
| (RF) for use in the calibration of AAT and RF | ||
| assays on the Bayer Advia 1650 analyser only. | ||
| for the calibration of a-1-antitrypsin, a-1-acid | ||
| glycoprotein, IgA, IgG, IgM and Transferrin | ||
| assays which require sample pre-dilution | ||
| Formulation / | ||
| analytes | ||
| present | Anti-streptolysin-O, | |
| Alpha-1-Antitrypsin, | ||
| Prealbumin, | ||
| Rheumatoid Factor, | ||
| Immunoglobulin A | ||
| Immunoglobulin G, | ||
| Immunoglobulin M | same | |
| Complement C3, | ||
| Complement C4, | ||
| Haptoglobin, | ||
| Transferrin, | ||
| Ferritin, | ||
| Alpha-acid-glycoprotein, | ||
| CRP | ||
| Measured | ||
| Analytes | ||
| (value | ||
| assigned) | Anti-streptolysin-O | |
| Alpha-1-Antitrypsin | ||
| Prealbumin, | ||
| Rheumatoid Factor, | ||
| Immunoglobulin A, | ||
| Immunoglobulin G, | ||
| Immunoglobulin M, | ||
| Complement C3, | ||
| Complement C4, | ||
| Haptoglobin, | ||
| Transferrin, | ||
| Alpha-acid-glycoprotein, | ||
| Ferritin - not value assigned but present in the | ||
| formulation, | ||
| CRP - not value assigned but present in the | ||
| formulation | ASO | |
| AAT | ||
| Prealbumin | ||
| RF | ||
| IgA | ||
| IgG | ||
| IgM | ||
| Complement C3 | ||
| Complement C4 | ||
| HAPT | ||
| Transferrin | ||
| Alpha-acid-glycoprotein | ||
| Ferritin | ||
| CRP | ||
| Instrument | ADVIA® Chemistry Systems | Clinical Chemistry and Immunoassay systems, |
| Abbott Spectrum, Abbott Acroset, Abbott | ||
| Architect i2000, Architect i2000sr, Ace | ||
| analyser, Bayer Advia 1650, Advia 2400, Advia | ||
| 1200, Dade Dimension RXL, Dimension AR, | ||
| Hitachi 704, Hitachi 717, | ||
| Hitachi 911, Hitachi 917, Hitachi 912, Hitachi | ||
| 747, Kone progress, AU800, | ||
| AU600, AU400, AU2700, AU5400, Selectra | ||
| Vitalab, Synchron CX4, Synchron | ||
| CX5, Synchron CX7, Synchron LX20, | ||
| ILAB300, ILAB900, ILAB1800, | ||
| ILAB600, RX Daytona, RX Imola, Cobas Mira, | ||
| Cobas Mira S, Cobas Mira Plus systems | ||
| Traceability | ||
| for AAG | International Reference Material CRM 470 | same |
| Matrix | Buffered base | same |
| Analyte | ||
| source | Derived from human source | same |
| Number of | ||
| levels | Six (the lowest level is a zero-level) | same |
| Fill Volume | 1.0 mL each vial | same |
| Stability | 24 months – shelf-life | same |
2
J. Conclusion:
r
The multi-analyte, six level ADVIA Chemistry Liquid Specific Protein Calibrator is substantially equivalent to the Randox Liquid Protein Calibrator. They are identical in composition and both used in calibration of multiple analytes on Chemistry systems.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a human profile.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Kira Gordon, Ph.D. Sr. Regulatory Affairs Specialist 511 Benedict Ave Tarrytown, NY 10591
FEB 1 8 2011
Re: K103701
Trade/Device Name: ADVIA® Chemistry Liquid Specific Protein Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: December 17, 2010 Received: December 20, 2010
Dear Dr. Gordon:
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 may of subject to and the may 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 or any I edelar statutes and regulations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
:
and the state of the state of the states of the states
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Page 2 – Kira Gordon, Ph.D.
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 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 regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please i note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
ia m chan
Maria M. Chan, 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
5
Indications for Use
K103701 510(k) Number (if known):
Device Name: ADVIA® Chemistry Liquid Specific Protein Calibrators
Indications For Use:
The ADVIA Chemistry Liquid Protein Calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the Alpha-Acid-Glycoprotein (AAG), Alpha-1-Antitrypsin (AAT), Anti-streptolysin-O_2 (ASO_2), Complement C3 (C3), Complement C4 (C4), Haptoglobin (HAPT), Immunoglobulin A_2 (IGA_2), Immunoglobulin G_2 (IGG_2), Immunoglobulin M 2 (IGM 2), Prealbumin (PREALB), Rheumatoid Factor (RF), Transferrin (TRF) methods
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Seena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety K103701 510(k)________________________________________________________________________________________________________________________________________________________________________
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