(237 days)
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No
The document describes quality control materials for a diagnostic assay and does not mention any AI or ML components in the device description or performance studies.
No.
This device is an in vitro diagnostic (IVD) quality control material used for verifying the calibration and reportable range of an assay. It is not used to treat or diagnose patients directly.
Yes
The "Intended Use / Indications for Use" section explicitly states that the calibration verifiers are "intended for in vitro diagnostic use." These verifiers are used to ensure the accuracy of an assay (LIAISON® 25 OH Vitamin D TOTAL Assay) that measures vitamin D levels, which is a diagnostic function to determine "Vitamin D sufficiency status in individual patients."
No
The device description clearly states the device consists of "four human serum-based total vitamin D levels with buffer salts and sodium azide" in vials, indicating a physical, chemical-based product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The DiaSorin LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use..."
This statement directly identifies the device as being intended for use in diagnostic procedures performed outside of the living body.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay when performed on the LIAISON® Analyzer.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers consist of four human serum-based total vitamin D levels with buffer salts and sodium azide. Each vial contains 5.0 mL of ready to use liquid material. The set is provided with targeted total vitamin D concentrations. The individual Calibration Verifier concentrations were chosen to represent values closest to the important decision limits used to determine Vitamin D sufficiency status in individual patients.
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)
REPRODUCIBILITY
Precision studies were conducted to verify the DiaSorin established performance of the LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers. Three Calibration Verifier lots were tested on 3 LIAISON® Analyzers. Each Calibration Verifier (A-D) was tested in quadruplicate, one run per day for 5 days. CLSI EP15-A2 was consulted in the study design. The LIAISON® 25 OH Vitamin D TOTAL Controls were tested as daily quality control for the assay.
The mean, standard deviation (SD), and coefficient of variance (%CV) for within run. between run, total by instrument, and overall were computed for each of the tested Calibration Verifiers.
Table 1: 5 day Precision study results
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Coefficient of Variance (%CV), Standard Deviation (SD)
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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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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114
SEP 0 9 2009
SUBMITTED BY:
5.0 510(k) SUMMARY
Kelly R. Sauer Regulatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 439-9710 Fax (651) 351-5669 Email: kelly.sauer@diasorin.com
NAME OF DEVICE:
Trade Name:
LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers
Vitamin D TOTAL Assayed Quality Control Materials
Single (Specified) Analyte Controls (Assaved and Unassayed)
21CFR 862.1660
Classification Number:
Classification Names:
Common Names/Descriptions:
Product Code:
PREDICATE DEVICES :
LIAISON® 25 OH Vitamin D TOTAL Control Set Reference K071480
DEVICE DESCRIPTION:
INTENDED USE:
The DiaSorin LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay when performed on the LIAISON® Analyzer.
JJX :
KIT DESCRIPTION:
The LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers consist of four human serum-based total vitamin D levels with buffer salts and sodium azide. Each vial contains 5,0 mL of ready to use liquid material. The set is provided with targeted total vitamin D concentrations. The individual Calibration Verifier concentrations were chosen to represent values closest to the important decision limits used to determine Vitamin D sufficiency status in individual patients.
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214
PERFORMANCE DATA:
REPRODUCIBILITY
Precision studies were conducted to verify the DiaSorin established performance of the LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers. Three Calibration Verifier lots were tested on 3 LIAISON® Analyzers. Each Calibration Verifier (A-D) was tested in quadruplicate, one run per day for 5 days. CLSI EP15-A2 was consulted in the study design. The LIAISON® 25 OH Vitamin D TOTAL Controls were tested as daily quality control for the assay.
The mean, standard deviation (SD), and coefficient of variance (%CV) for within run. between run, total by instrument, and overall were computed for each of the tested Calibration Verifiers.
| Cal Verifier | | Expected
Range | mean
conc | Within run | | Between
run | | Total (by
instrument) | | overall | |
|--------------|----|-------------------|--------------|------------|-----|----------------|------|--------------------------|------|---------|------|
| ID# | N | ng/mL | ng/mL | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| A Lot #1 | 60 | 7.1 - 13.3 | 10.5 | 0.66 | 6.4 | 1.19 | 11.3 | 1.26 | 12.0 | 1.35 | 12.9 |
| B Lot #1 | 60 | 29.9 - 48.9 | 41.9 | 1.98 | 4.8 | 3.44 | 8.2 | 3.70 | 8.8 | 3.71 | 8.9 |
| C Lot #1 | 60 | 54.5 - 81.7 | 71.4 | 2.33 | 3.3 | 5.54 | 7.7 | 5.59 | 7.8 | 5.66 | 7.9 |
| D Lot #1 | 60 | 92.9 - 139.3 | 122.6 | 4.04 | 3.3 | 9.55 | 7.8 | 9.72 | 7.9 | 9.63 | 7.9 |
| A Lot #2 | 60 | 7.1 - 13.3 | 9.7 | 0.64 | 6.5 | 1.36 | 14.1 | 1.39 | 14.4 | 1.42 | 14.6 |
| B Lot #2 | 60 | 30.7 - 50.1 | 40.3 | 2.15 | 5.3 | 3.99 | 9.9 | 4.29 | 10.6 | 4.23 | 10.5 |
| C Lot #2 | 60 | 56.6 - 85.0 | 72.4 | 3.23 | 4.5 | 5.14 | 7.1 | 5.78 | 8.0 | 5.86 | 8.1 |
| D Lot #2 | 60 | 90.5 - 135.7 | 116.3 | 4.01 | 3.5 | 6.84 | 5.9 | 7.56 | 6.5 | 8.01 | 6.9 |
| A Lot #3 | 60 | 7.9 - 14.7 | 10.6 | 0.61 | 5.8 | 0.91 | 8.6 | 1.03 | 9.7 | 1.03 | 9.7 |
| B Lot #3 | 60 | 32.9 - 53.6 | 40.7 | 2.37 | 5.8 | 1.88 | 4.6 | 2.90 | 7.1 | 3.18 | 7.8 |
| C Lot #3 | 60 | 59.0 - 88.5 | 67.9 | 2.60 | 3.8 | 2.59 | 3.8 | 3.43 | 5.0 | 3.76 | 5.5 |
| D Lot #3 | 60 | 97.2 - 145.8 | 111.1 | 3.64 | 3.3 | 3.99 | 3.5 | 5.41 | 4.8 | 6.51 | 5.9 |
Table 1: 5 day Precision study results
2
COMPARISON TO PREDICATE DEVICE:
The following table compares the LIAISON® 25 OH Vitamin D TOTAL Calibration
Verifiers to LIAISON® 25 OH Vitamin D TOTAL Control Set. ·
| Characteristic | Predicate Device
LIAISON® 25 OH Vitamin D
TOTAL Control Set
K071480 | New Device
LIAISON® 25 OH Vitamin D
TOTAL Calibration Verifiers |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Assayed quality control
samples to monitor the
accuracy and precision of the
DiaSorin LIAISON® 25 OH
Vitamin D TOTAL Assay | Assayed quality control
materials for in vitro
diagnostic use in the
quantification verification of
calibration and reportable
range of the DiaSorin
LIAISON® 25 OH Vitamin D
TOTAL Assay when
performed on the LIAISON®
Analyzer |
| Analyte | Total
25-hydroxyvitamin D | Total
25-hydroxyvitamin D |
| Format | Provided ready to use
Liquid | Provided ready to use
Liquid |
| Product Handling | Transfer 250 µL to test tube
and place on LIAISON®
Analyzer
Discard unused portion | Transfer 250 µL to test tube
and place on LIAISON®
Analyzer
Discard unused portion |
| Processing | Automated LIAISON®
Analyzer | Automated LIAISON®
Analyzer |
| Product Storage | 2 to 8°C | 2 to 8°C |
| Required Reagent | LIAISON® 25 OH
Vitamin D TOTAL Assay | LIAISON® 25 OH
Vitamin D TOTAL Assay |
| Matrix | Vitamin D free human serum
with buffer salts and Trade Name: Liaison 25 OH Vitamin D Total Calibration Verifiers Regulation Number: 21 CFR §862.1660 Regulation Name: Single (Specified) Analyte Controls (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: July 27, 2009 Received: July 29, 2009
Dear Ms. Sauer:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
G.C.H
Courtney C. Harper, Ph.D. Acting 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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Indication for Use
510(k) Number (if known): K090104
Device Name:
LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers
Indication For Use:
The DiaSorin LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay when performed on the LIAISON® Analyzer.
Prescription Use X (21 CFR Part 801 Subpart D)
Over th
(21-27
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090104