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.

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.

AI/ML Overview

The 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.

Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated by the "Expected Range" for each Calibration Verifier level. The reported device performance, in terms of precision (SD and %CV for overall results), falls within or is expected to enable the LIAISON® 25 OH Vitamin D TOTAL Assay to operate within these ranges.

Cal Verifier ID#	Expected Range (ng/mL)	Overall Mean Conc (ng/mL)	Overall SD	Overall %CV
A Lot #1	7.1 - 13.3	10.5	1.35	12.9
B Lot #1	29.9 - 48.9	41.9	3.71	8.9
C Lot #1	54.5 - 81.7	71.4	5.66	7.9
D Lot #1	92.9 - 139.3	122.6	9.63	7.9
A Lot #2	7.1 - 13.3	9.7	1.42	14.6
B Lot #2	30.7 - 50.1	40.3	4.23	10.5
C Lot #2	56.6 - 85.0	72.4	5.86	8.1
D Lot #2	90.5 - 135.7	116.3	8.01	6.9
A Lot #3	7.9 - 14.7	10.6	1.03	9.7
B Lot #3	32.9 - 53.6	40.7	3.18	7.8
C Lot #3	59.0 - 88.5	67.9	3.76	5.5
D Lot #3	97.2 - 145.8	111.1	6.51	5.9

The acceptance criteria are not explicitly stated for the device's own performance (e.g., maximum allowable %CV for a verifier), but rather the verifiers are designed to confirm the calibration and reportable range of the LIAISON® 25 OH Vitamin D TOTAL Assay. The study demonstrates the reproducibility of the verifiers themselves, indicating their stability and consistency for their intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: For each of the four Calibration Verifier levels (A, B, C, D) across three different lots, the sample size (N) for the precision study was 60. This was achieved by testing each verifier in quadruplicate, one run per day for 5 days, across 3 LIAISON® Analyzers (4 measurements/day * 5 days/run * 3 analyzers = 60).
Data Provenance: The document does not specify the country of origin of the data. It is highly likely to be internal data from DiaSorin Inc., given the direct reference to their established performance and the conduct of the study to verify that performance. The study is prospective as it involves controlled testing under defined conditions specifically to assess the device's reproducibility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the device is an assayed quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth. The "ground truth" for the Calibration Verifiers are their targeted total vitamin D concentrations, which would have been established by DiaSorin using a reference method or validated internal process during their manufacturing and assaying.

4. Adjudication Method for the Test Set

This section is not applicable. The study involves quantitative measurements by automated analyzers, not subjective assessments requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a quality control material for an automated assay, not an imaging device or diagnostic tool requiring human interpretation. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance study was done in the sense that the performance of the Calibration Verifiers was evaluated independent of human interpretation of results, using automated LIAISON® Analyzers. The focus was on the analytical reproducibility of the verifiers themselves when processed by the LIAISON® system.

7. The Type of Ground Truth Used

The ground truth for the Calibration Verifiers themselves is their "targeted total vitamin D concentrations" (as stated in the device description). These concentrations are established during the manufacturing and assaying of the control materials, likely using highly accurate reference methods or certified reference materials to assign the values.

8. The Sample Size for the Training Set

This section is not applicable. The LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers are quality control materials, not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a training set. Their "targeted concentrations" are assigned through analytical processes, not learned from data.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

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:

JJX :

KIT DESCRIPTION:

{1}------------------------------------------------

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		ExpectedRange	meanconc	Within run		Betweenrun		Total (byinstrument)		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 DeviceLIAISON® 25 OH Vitamin DTOTAL Control SetK071480	New DeviceLIAISON® 25 OH Vitamin DTOTAL Calibration Verifiers
Intended Use	Assayed quality controlsamples to monitor theaccuracy and precision of theDiaSorin LIAISON® 25 OHVitamin D TOTAL Assay	Assayed quality controlmaterials for in vitrodiagnostic use in thequantification verification ofcalibration and reportablerange of the DiaSorinLIAISON® 25 OH Vitamin DTOTAL Assay whenperformed on the LIAISON®Analyzer
Analyte	Total25-hydroxyvitamin D	Total25-hydroxyvitamin D
Format	Provided ready to useLiquid	Provided ready to useLiquid
Product Handling	Transfer 250 µL to test tubeand place on LIAISON®AnalyzerDiscard unused portion	Transfer 250 µL to test tubeand place on LIAISON®AnalyzerDiscard unused portion
Processing	Automated LIAISON®Analyzer	Automated LIAISON®Analyzer
Product Storage	2 to 8°C	2 to 8°C
Required Reagent	LIAISON® 25 OHVitamin D TOTAL Assay	LIAISON® 25 OHVitamin D TOTAL Assay
Matrix	Vitamin D free human serumwith buffer salts and <0.1%sodium azide	Vitamin D free human serumwith buffer salts and <0.1%sodium azide
Table 2: Table of Differences
Characteristic	Predicate DeviceLIAISON® 25 OH Vitamin D TOTAL Control Set K071480	New DeviceLIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers
Levels	Two	Four
Volume	4.0 mLs	5.0 mLs

{3}------------------------------------------------

K090104

414

CONCLUSION:

The material submitted in this premarket notification is complete and supports the substantial equivalence of the LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers to the predicate device.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

SEP 0 9 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Diasorin, Inc. c/o Ms. Kelly R. Sauer Regulatory Affairs Specialist 1951 Northwestern Avenue P. O. Box 285 Stillwater, MN 55082-0285

Re: K090104

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).

{5}------------------------------------------------

Page 2

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

{6}------------------------------------------------

Indication for Use

510(k) Number (if known): K090104

Device Name:

LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers

Indication For Use:

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

Regulation Number and Section

§ 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.