The LIAISON® N-TACT® PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON® XL Analyzer.

The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay.

The LIAISON® N-TACT® PTH Gen II Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Gen II assay.

Device Description

The LIAISON® N-TACT® PTH Gen II assay is a modified two-step, two-site sandwich assay that uses two goat polyclonal antibodies for capture and detection of intact PTH. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of intact PTH present in the calibrators, controls or samples.

LIAISON® N-TACT® PTH Gen II Control set contains:
2 levels controls containing 80% human plasma spiked with 1-84 PTH, and preservatives; 4 vials each level; lyophilized
The target concentration for control level 1 is 20 pg/mL. The target concentration for control Level 2 is 300 pg/mL.
The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Control set.

LIAISON® N-TACT® PTH Gen II Calibration Verifier set contains:
4 levels containing 80% human plasma spiked with 1-84 PTH, with preservative, . 1 vial each level, lyophilized
The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 150 pg/mL. The target concentration for cal verifier C is 650 pg/mL. The target concentration for cal verifier D is 1600 pg/mL.
The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Calibration Verifier set.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the LIAISON® N-TACT® PTH Gen II device based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIAISON® N-TACT® PTH Gen II primarily demonstrates substantial equivalence to a predicate device. As such, the "acceptance criteria" are generally implied by the performance of the predicate device and the demonstration that the new device performs comparably or better, meeting established clinical laboratory guidelines. Specific numeric acceptance criteria are not explicitly stated in a "PASS/FAIL" format for each performance characteristic, but rather the study results are presented to show satisfactory performance.

Here's a table summarizing the performance characteristics and their reported results, which implicitly serve as the demonstration of meeting acceptance:

Performance Characteristic	Acceptance Criteria (Implied / Predicate Performance)	Reported Device Performance (LIAISON® N-TACT® PTH Gen II)
Method Comparison (vs. Predicate)	Substantial equivalence to Siemens ADVIA® CENTAUR INTACT iPTH (K020217)	n=198 Slope: 1.010 (95% CI: 0.99 to 1.03) Intercept: -1.5851 pg/mL (95% CI: -3.11 to -0.44) Correlation coefficient (r): 0.9953
Measuring Range	Comparable to predicate (2.5 - 1900 pg/mL)	3 - 1900 pg/mL
Sample Matrix Equivalence	Equivalent results across EDTA plasma, serum, SST serum, Lithium Heparin plasma	EDTA plasma vs. Serum: Slope 0.97, Int. -2.45, R² 0.9986 EDTA plasma vs. SST Serum: Slope 1.01, Int. -2.25, R² 0.9996 EDTA plasma vs. Lithium Heparin: Slope 0.98, Int. -0.01, R² 0.9991
Reference Range	Established and clinically appropriate	14.5 - 87.1 pg/mL (n=125 healthy adults from US)
Precision	Demonstrated by low %CVs across various PTH levels (following CLSI EP5-A2)	Total %CVs across lots (selected examples): 19.3 pg/mL: 3.3% 250 pg/mL: 3.5% 12.6 pg/mL: 4.2% 1477 pg/mL: 2.8%
Linearity	Linear response across the assay range (following CLSI EP6-A)	R² for various matrices: Serum: 0.9982, SST Serum: 0.9987, EDTA plasma: 0.9983, Lithium Heparin plasma: 0.9992 (all close to 1, indicating linearity)
High Dose Hook Effect	No hook effect within a specified range	No hook effect observed up to 1,000,000 pg/mL of PTH
Recovery	Acceptable percentage recovery values	Mean Recovery: 97% (range 93%-103% across various spiked samples)
Analytical Specificity (Cross-Reactivity)	Minimal cross-reactivity with related substances	PTH (7-84): 53% Other PTH fragments, Calcitonin, C-Telopeptide, Osteocalcin: < 0.01%
Interference Studies (Endogenous)	No significant interference with common endogenous substances (≤ ±10%)	No significant interference at specified concentrations (e.g., Hemoglobin 500 mg/dL, Bilirubin 40 mg/dL, Triglycerides 3,000 mg/dL, etc.)
Interference Studies (Exogenous)	No significant interference with common exogenous substances (≤ ±10%)	No significant interference at specified concentrations (e.g., Acetaminophen 0.2 mg/mL, Ibuprofen 0.5 mg/mL, various bisphosphonates, vitamins, calcium/magnesium/aluminum salts)
Limit of Blank (LoB)	Low LoB value	< 0.5 pg/mL
Limit of Detection (LoD)	Low LoD value	5 pg/mL
Limit of Quantitation (LoQ)	Low LoQ value	3.0 pg/mL
Stability (Reagent Integral on system)	Acceptable on-board stability	56 days
Stability (Calibration curve)	Acceptable calibration interval	28 days

Study Details for LIAISON® N-TACT® PTH Gen II

Sample sizes used for the test set and data provenance:
- Method Comparison: 198 patient samples. The provenance is not explicitly stated as country of origin, but the reference range study mentions "northern and southern regions of the U.S.", suggesting US-based samples for some studies. The study is retrospective, utilizing existing patient samples.
- Sample Matrix Comparison: 65 matched patient sets (EDTA plasma, serum, SST serum, and Lithium Heparin plasma). Data provenance is not explicitly stated beyond being "patient sets." Retrospective.
- Reference Range: 125 apparently healthy adults aged 21-70 years from mixed ethnic backgrounds (32.5% dark-skinned, 66.7% light-skinned, 0.8% unknown) from the northern and southern regions of the U.S. This is a prospective or retrospective collection of samples for establishing a reference interval.
- Precision: 7 frozen EDTA plasma samples (coded panel) and 2 lots of LIAISON® N-TACT® PTH Gen II controls (2 levels). Samples were tested on two lots of reagents. This is a controlled lab study, not involving patient data per se beyond the initial source of the plasma samples.
- Linearity: One sample pool of each type: serum, SST serum, EDTA plasma, and Lithium Heparin plasma. These were diluted. Controlled lab study.
- High Dose Hook Effect: A zero sample spiked with PTH. Controlled lab study.
- Recovery Study: 5 high concentration EDTA plasma samples and 5 low concentration EDTA plasma samples. Controlled lab study, not directly patient data.
- Analytical Specificity (Cross-Reactivity & Interference): Samples spiked with specific substances. These are controlled lab studies.
- Limit of Blank, Limit of Detection, Limit of Quantitation: Not explicitly stated, usually involves multiple replicates of blank and low-concentration samples. Controlled lab study.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This device is an in vitro diagnostic (IVD) immunoassay, not an image-based AI device. The "ground truth" is established through analytical methods and comparison to established, cleared diagnostic devices (predicate device) and clinical standards, rather than expert human interpretation.
- For the method comparison, the "ground truth" for the test set is the result from the predicate device, Siemens ADVIA® CENTAUR INTACT Parathyroid Hormone (iPTH) Assay, which is an FDA-cleared device.
- For other analytical performance studies (precision, linearity, recovery, etc.), the ground truth relies on carefully prepared samples with known concentrations or expected behaviors, measured against established analytical principles and validated laboratory methods. There are no "experts" establishing image-based ground truth here.
Adjudication method for the test set:
- Not applicable as this is an IVD immunoassay, not a diagnostic imaging AI where human adjudication of ambiguous cases is typically required. The comparison is objective, numerical data between two analytical methods or against defined analytical targets.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is an IVD assay, not an AI-powered diagnostic imaging tool that assists human readers. The performance is assessed against a predicate device and analytical standards.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The LIAISON® N-TACT® PTH Gen II assay is a standalone device in the sense that it provides quantitative results for PTH concentration. It operates autonomously on the LIAISON® XL Analyzer without direct human interpretation of the result generation process. Interpretation of the PTH level in a clinical context (e.g., diagnosis of hyper/hypocalcemia) still involves human clinicians, but the device provides the raw measurement itself without human input into the measurement.
The type of ground truth used:
- For Method Comparison: Results from the predicate device (Siemens ADVIA® CENTAUR INTACT PTH (iPTH) Assay, K020217).
- For other analytical studies (Precision, Linearity, Recovery, etc.): Typically based on known concentrations of analytes in spiked samples or reference materials, or expected analytical behaviors according to established CLSI guidelines (e.g., EP5-A2 for Precision, EP6-A for Linearity, EP7-A2 for Interference, EP17-A2 for Detection Capability). For the reference range, it's derived from a healthy population cohort carefully selected using specific clinical criteria.
The sample size for the training set:
- This document describes performance characteristics for an IVD kit, not an AI/Machine Learning model. Therefore, there isn't a "training set" in the sense of data used to train an algorithm. The development of the assay itself would involve internal optimization and validation, but these stages are not typically referred to as "training sets" in the context of conventional IVDs in 510(k) summaries.
How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML context, this question is not applicable. The assay's analytical characteristics are developed and verified through standard laboratory practices and comparison to reference methods, not through an iterative learning process with labeled data.

Summary

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510(k) Summary

LIAISON® N-TACT® PTH Gen II LIAISON® N-TACT® PTH Gen II Control Set LIAISON® N-TACT® PTH Gen II Calibration Verifiers

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

1. 510{k} Number: K132515

1. Applicant: Carol A. DePouw
  DiaSorin Inc. 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 Office Number: 651-351-5850; Fax Number: 651-351-5669 Email: carol.depouw@diasorin.com

3. Date: September 4, 2013

4. Proprietary and Established Names:

LIAISON® N-TACT® PTH Gen II LIAISON® N-TACT® PTH Gen II Control Set LIAISON® N-TACT® PTH Gen II Calibration Verifiers

NOV 0 8 2013

5. Regulatory Information:

LIAISON® N-TACT® PTH Gen II

Regulation Section: 21 CFR 862.1545 Classification: Class II Product Code: CEW Panel: Clinical Chemistry (75)

LIAISON® N-TACT® PTH Gen II Control Set LIAISON® N-TACT® PTH Gen II Calibration Verifiers

Regulation Section: 21 CFR 862.1660 Classification: Class I, reserved Product Code: JJX Panel: Clinical Chemistry (75)

6. Predicate Devices:

The predicate device used to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen II is the Siemens ADVIA® CENTAUR INTACT Parathyroid Hormone (iPTH) Assay previously cleared under K020217.

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The predicate device used to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen II Control Set is the LIAISON® N-TACT® PTH Control Set previously cleared under K033426.

The predicate device used to demonstrate substantial equivalence to the LIAISON® N-TACT® PTH Gen II Calibration Verifiers is the LIAISON® N-TACT® PTH Calibration Verifiers previously cleared under K093498.

7. Device Description:

ﻤﺪ 1

The LIAISON® N-TACT® PTH Gen II assay is a modified two-step, two-site sandwich assay that uses two goat polyclonal antibodies for capture and detection of intact PTH. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of intact PTH present in the calibrators, controls or samples.

LIAISON® N-TACT® PTH Gen II Control set contains:

. 2 levels controls containing 80% human plasma spiked with 1-84 PTH, and preservatives; 4 vials each level; lyophilized
The target concentration for control level 1 is 20 pg/mL. The target concentration for control Level 2 is 300 pg/mL.

The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Control set.

LIAISON® N-TACT® PTH Gen II Calibration Verifier set contains:

4 levels containing 80% human plasma spiked with 1-84 PTH, with preservative, . 1 vial each level, lyophilized
The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 150 pg/mL. The target concentration for cal verifier C is 650 pg/mL. The target concentration for cal verifier D is 1600 pg/mL.

The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Calibration Verifier set.

8. Intended Use:

The test is to be performed on the LIAISON® XL Analyzer.

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The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay.

9. Indication(s) for Use:

Same as Intended Use

10. Substantial Equivalence Information:

Both the LIAISON® N-TACT® PTH Gen II and the predicate Siemens ADVIA CENTAUR® INTACT Parathyroid Hormone (iPTH) Assay are prepackaged reagents for use on automated clinical chemistry analyzers. A comparison of the similarities and differences between the devices are provided in the following table:

Characteristic	Candidate DeviceLIAISON® N-TACT® PTH Gen II	Predicate DeviceADVIA Centaur iPTH (K020217)
Intended Use	For in vitro quantitative determinationof intact human parathyroid hormone	For in vitro quantitative determinationof intact parathyroid hormone
Measured Analyte	Intact Parathyroid Hormone	Intact Parathyroid Hormone
Calibration	Two-point calibration	Two-point calibration
Antibody	Goat polyclonal	Goat polyclonal
Reagent Storage	On-board or in refrigerator @ 2-8°C	On-board or in refrigerator @ 2-8°C
Measuring range	3 - 1900 pg/mL	2.5 - 1900 pg/mL
Sample Matrix	EDTA Plasma, Serum, SST serumand Lithium Heparin plasma	EDTA Plasma and Serum
Sample size	150 µL	200 µL
Open storageon analyzer	56 days	28 days
Calibration interval	28 days	14 days
Calibrators	2 levels - Included with kit	2 Levels - Not included with kit
Manufacturers	2 levels	3 levels
Controls
Reference range	14.5 - 87.1 pg/mL	11.1 - 79.5 pg/mL

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	Control Similarities and Differences
Characteristic	Candidate DeviceLIAISON® N-TACT® PTH Gen IIControl Set	Predicate DeviceLIAISON® N-TACT® PTHControl Set (K033426)
Intended Use	intended for use as assayed qualitycontrol samples to monitor theaccuracy and precision of theLIAISON® N-TACT® PTH Gen II	intended for use as assayed qualitycontrol samples to monitor theaccuracy and precision of theLIAISON® N-TACT® PTH
Storage	Store at 2-8°C until ready to use	Same
Levels	2 levels: lyophilizedLevel 1 (approx 20 pg/mL)Level 2 (approx 300 pg/mL)	2 levels: lyophilizedLevel 1 (approx 60 pg/mL)Level 2 (approx 560 pg/mL)

Calibration Verifiers Similarities and Differences
Characteristic	Candidate DeviceLIAISON® N-TACT® PTH Gen IICalibration Verifiers	Predicate DeviceLIAISON® N-TACT® PTHCalibration Verifiers (K093498)
Intended Use	assayed quality control materialsintended for the quantitativeverification of calibration andreportable range of the LIAISON®N-TACT® PTH Gen II	assayed quality control materialsintended for the quantitativeverification of calibration andreportable range of the LIAISON®N-TACT® PTH
Storage	2 to 8°C	Same
Levels	4 levels; lyophilizedCal Ver A (approx 10 pg/mL)Cal Ver B (approx 150 pg/mL)Cal Ver C (approx 650 pg/mL)Cal Ver D (approx 1600 pg/mL)	4 levels; lyophilizedCal Ver A (approx 20 pg/mL)Cal Ver B (approx 150 pg/mL)Cal Ver C (approx 350 pg/mL)Cal Ver D (approx 1500 pg/mL)
Volume	2.0 mLs	Same

11. Standard/guidance Document Reference:

CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods;
CLSI Guideline EP6-A, Evaluation of Linearity of Quantitative Analytical Methods; o
CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry, o
CLSI Guideline EP9-A2-IR, Method Comparison and Bias Estimation Using O Patient Samples:
CLSI Guideline EP17-A2 Evaluation of Detection Capability for Clinical o Laboratory Measurement Procedures;
CLSI Guideline C28-A3, Defining, Establishing and Verifying Reference Intervals o in the Clinical Laboratory.

12. Performance Characters:

Method Comparison

A method comparison study was performed following CLSI EP9-A2, individual results for the Siemens ADVIA Centaur® Intact PTH (iPTH) and the LIAISON® N-TACT® PTH

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Gen II were plotted. Passing & Bablok linear regression analyses were performed and gave the following results:

Passing & Bablok Fit
n	Slope	95% CI	Interceptpg/mL	95% CI	Correlationcoefficient (r)
198	1.010	0.99 to 1.03	-1.5851	-3.11 to -0.44	0.9953

Sample Matrix Comparison

Sixty-five (65) matched patient sets of EDTA plasma, serum, SST serum, and Lithium Heparin plasma samples were tested to determine if these sample types provide equivalent results on the LIAISON® N-TACT® PTH Gen II assay. The following Passing & Bablok linear regression results were obtained:

EDTA plasma vs.	Slope	95% CI	Interceptpg/mL	95% CI	R2
Serum	0.97	0.94 to 1.0	-2.45	-4.05 to -1.51	0.9986
SST Serum	1.01	0.99 to 1.03	-2.25	-3.10 to -1.44	0.9996
Lithium Heparin	0.98	0.97 to 1.01	-0.01	-1.05 to 0.74	0.9991

Reference Range

EDTA plasma samples from125 apparently healthy adults aged 21 - 70 years of age from mixed ethnic backgrounds (32.5% dark -skinned, 66.7% light-skinned and 0.8% unknown) with normal Total Calcium, TSH, Phosphorus, Magnesium, Creatinine, Alkaline Phosphatase and 25 OH Vitamin D values from the northern and southern regions of the U.S.

LIAISON® N-TACT® PTH Gen II Reference Range

Population(n =125)	MedianPTH (pg/mL)	Observed Range2.5th to 97.5th Percentile
United States	34.00	14.5 - 87.1 pg/mL

Precision

Precision testing was performed following CLSI Guideline EP5-A2. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline -Second Edition. A coded panel comprised of 7 frozen EDTA plasma samples spanning the assay range and 2 lots of LIAISON® N-TACT® PTH Gen II controls (2 levels) were fested in the study. The precision panel samples and kit controls were tested on two lots of LIAISON® N-TACT® PTH Gen II in two replicates per run, 2 runs per day for 20 operating days for a total of 160 replicate results per sample. The 20 day results are summarized for the combined reagent lot numbers as sample mean PTH concentration in pg/mL, standard deviations and coefficient of variation (%CV) for between lot and Total across lots.

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		MeanPTH(pg/mL)	Between-Lot		Total(Across Lots)
Sample ID	n		SD	%CV	SD	%CV
Lot 1 Kit Control Level 1	160	19.3	0.26	1.3%	0.65	3.3%
Lot 1 Kit Control Level 2	160	250	9.27	3.7%	8.84	3.5%
Lot 2 Kit Control Level 1	160	18.5	0.28	1.5%	0.57	3.1%
Lot 2 Kit Control Level 2	160	252	10.59	4.2%	9.05	3.6%
EDTA Plasma 1	160	12.6	0.23	1.8%	0.53	4.2%
EDTA Plasma 2	160	34.5	0.70	2.0%	1.38	4.0%
EDTA Plasma 3	160	86.2	1.68	1.9%	3.07	3.6%
EDTA Plasma 4	160	156.1	5.25	3.4%	5.54	3.5%
EDTA Plasma 5	160	605	24.62	4.1%	19.37	3.2%
EDTA Plasma 6	160	1348	46.58	3.5%	44.06	3.3%
EDTA Plasma 7	160	1477	84.06	5.7%	40.62	2.8%

Linearity

One sample pool of each type; serum, SST serum, EDTA plasma and Lithium Heparin plasma were diluted and analyzed by the LIAISON® N-TACT® PTH Gen II assay following CLSI EP6-A. The results were analyzed by a weighed Deming regression of Observed PTH Concentration versus Expected PTH Concentration.

The resulting equations for each sample types are: Serum: Observed PTH = 0.9767x - 3.624; R2 = 0.9982 SST Serum: Observed PTH = 0.9742x + 3.856; R2 = 0.9987 EDTA plasma: Observed PTH = 1.012x ~ 4.127; R2 = 0.9983 Lithium Heparin plasma: Observed PTH = 0.9461x + 3.696; R2 = 0.9992

High Dose Hook Effect

Testing was conducted to determine if the LIAISON® N-TACT® PTH Gen II assay is susceptible to artificially low results in the presence of very high levels of PTH (Hook Effect). A zero sample was spiked with enough 1-84 PTH to equal concentrations above the assay measuring range of 1900 pg/mL.

No hook effect was observed up to 1,000,000 pg/mL of PTH.

Recovery Study

Five (5) high concentration EDTA plasma samples and 5 low concentration samples EDTA plasma samples were analyzed neat on the LIAISON® N-TACT® PTH Gen II assay. Recovery samples were then prepared by mixing defined ratios of the high and low samples and tested in replicates of 5. The observed values were compared to the expected values to determine the % recovery.

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	Defined	Expected	Observed	% Recovery
High Sample 1 (HS1)	999
2 HS1 : 1 LS1		695	674	97%
1 HS1 : 1 LS1		539	523	97%
1 HS1 : 2 LS1		383	358	93%
Low Sample 1 (LS1)	79.8
High Sample 2 (HS2)	1416
2 HS2 : 1 LS2		1003	992	99%
1 HS2 : 1 LS2		790	794	100%
1 HS2 : 2 LS2		577	590	102%
Low Sample 2 (LS2)	164
High Sample 3 (HS3)	696
2 HS3 : 1 LS3		479	495	103%
1 HS3 : 1 LS3		367	369	101%
1 HS3 : 2 LS3		255	237	93%
Low Sample 3 (LS3)	37.7
High Sample 4 (HS4)	1630
2 HS4 : 1 LS4		1174	1118	95%
1 HS4 : 1 LS4		939	906	96%
1 HS4 : 2 LS4		704	668	95%
Low Sample 4 (LS4)	248
High Sample 5 (HS5)	46.4
2 HS5 : 1 LS5		32.6	30.3	93%
1 HS5 : 1 LS5		25.5	23.8	93%
1 HS5 : 2 LS5		18.4	18.4	100%
Low Sample 5 (LS5)	4.7
		Mean Recovery		97%

Analytical Specificity

Cross-Reactivity Studies

CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline; Second Edition.

Controlled studies of potentially cross-reacting substances were performed on the LIAISON® N-TACT® PTH Gen II assay at the concentrations listed below.

Cross-Reactant	SpikedConcentration	% CrossReactivity
PTH (7 - 84)	1200 pg/mL	53%
PTH (1 - 34)	200,000 pg/mL	< 0.01%
PTH (39 - 68)	200,000 pg/mL	< 0.01%
PTH (44 - 68)	200,000 pg/mL	< 0.01%
PTH (39 - 84)	200,000 pg/mL	< 0.01%
PTH (53 - 84)	200,000 pg/mL	< 0.01%
Calcitonin	200,000 pg/mL	< 0.01%
C-Telopeptide (ß crosslaps)	200,000 pg/mL	< 0.01%
Osteocalcin	200,000 pg/mL	< 0.01%

Interference Studies

Controlled studies of potentially interfering endogenous substances performed in EDTA plasma at two PTH levels (70 and 150 pg/mL) showed no interference in the

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LIAISON® N-TACT® PTH Gen II at the highest concentration for each substance listed below.

Drug/Substance	Concentration at which no significant interference (≥±10%) was observed
Hemoglobin	500 mg/dL
Bilirubin (conjugated)	40 mg/dL
Bilirubin (unconjugated)	20 mg/dL
Triglycerides	3,000 mg/dL
Cholesterol	500 mg/dL
Albumin	12 g/dL
Rheumatoid Factor	2760 ng/mL
HAMA	611.8 IU/mL

Controlled studies of potentially interfering exogenous substances performed in EDTA plasma at two PTH levels (70 and150 pg/mL) showed no interference in the LIAISON® N-TACT® PTH Gen II assay.

Drug/Substance	Concentration atwhich no significantinterference (≥ ±10%)was observed.
Acetaminophen	0.2 mg/mL
Acetylsalicylic Acid	0.65 mg/mL
Salicylic Acid	0.6 mg/mL
lbuprofen	0.5 mg/mL
Alendronate	0.08 mg/mL
Etidronate	1.05 mg/mL
Pamidronate	0.18 mg/mL
Risedronate	0.06 mg/mL
Vitamin D2	240 ng/mL
Vitamin D3	240 ng/mL
Calcitriol	1 ng/mL
Alfacalcidol	2.5 µg/mL
Biotin	1 ug/mL
Calcium Acetate	0.4 mg/mL
Calcium Citrate	0.4 mg/mL
Magnesium Chloride	0.4 mg/mL
Aluminum Sulfate	0.4 mg/mL
Lanthanum Chloride	0.4 mg/mL

Limit of Blank, Limit of Detection and Limit of Quantitation

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline June 2012- Second Edition.

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The following limits were determined with the LIAISON® N-TACT® PTH Gen II Assay:
----------------------------------------------------------------------------------	--	--	--	--

t- UE	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------CCUL	LOG
< 0.5 pa/mL	5 pa/mL	3.0 pg/mLAnd Annual Annual Annual Annual

Stability

Product	Storage Conditions		Claimed stability
Reagent Integral	Open vial	on system	56 days
Calibrators	Open vial - Reconstituted	on system	8 hours
Calibrators	Open vial - Reconstituted	2-8°C	48 hours
Calibration curve	N/A	N/A	28 days
Controls	Open vial - Reconstituted	Room temp	7 hours
Controls	Open vial - Reconstituted	2-8°C	8 hours
Calibration Verifiers	Open vial - Reconstituted	Room temp	7 hours
Calibration Verifiers	Open vial - Reconstituted	2-8°C	8 hours

Traceability

The LIAISON® N-TACT® PTH Gen II Calibrators, Controls and Calibration Verifiers are traceable to an in-house standard preparation referenced to the WHO International standard, PTH human recombinant, NIBSC 95/646.

Value Assignment

Calibrators

A minimum of 5 vials of each level of calibrator are tested on a minimum of 3 LIAISON® XL Analyzers, in a minimum of 5 assay runs with six replicates per vial resulting in a minimum of 30 individual replicate results per calibrator level for final value assignment.

Controls

A minimum of 10 vials of each level of control are tested on 2 different LIAISON® N-TACT® PTH Gen II assay kit lots on a minimum of 3 LIAISON® XL Analyzers, in a minimum of 5 assay runs with 4 replicates per vial resulting in a minimum of 40 individual replicate results per control level for final value assignment.

Calibration Verifiers

A minimum of 12 vials of each level of calibration verifier are tested on 2 different LIAISON® N-TACT® PTH Gen II assay kit lots on a minimum of 4 LIAISON® XL Analyzers, in a minimum of 6 assay runs with 4 replicates per vial resulting in a minimum of 48 individual replicate results per control level for final value assignment.

13. Conclusion:

The LIAISON® N-TACT® PTH Gen II, LIAISON® N-TACT® PTH Gen II Control Set and the LIAISON® N-TACT® PTH Gen II Calibration Verifiers are substantially equivalent in principle and performance to the Siemens ADVIA® CENTAUR INTACT Parathyroid Hormone (iPTH) Assay, the LIAISON® N-TACT® PTH Control Set and the LIAISON® N-TACT® PTH Calibration Verifiers, respectively.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle of text that reads "U.S. Department of Health & Human Services USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO&G-Good Silver Spring, MI> 20993-0002

November 8, 2013

DiaSorin Inc. Ms. Carol A. DePouw 1951 Northwestern Ave. P.O. Box 285 STILLWATER MN 55082-0285

Re: K132515

Trade/Device Name: LIAISON N-TACT PTH Gen II. LIAISON N-TACT PTH Gen II Control Set. LIAISON N-TACT PTH Gen II Calibration Verifiers Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW. JJX Dated: October 23, 2013 Received: October 25, 2013

Dear Ms. DePouw:

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. Ilisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. DePouw

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. Also, please 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/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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510{k) Number (if known)

K132515

Device Name

LIAISON® N-TACT® PTH Gen II LIAISON® N-TACT® PTH Gen II Control Set LIAISON® N-TACT® PTH Gen II Calibration Verifiers

Indications for Use (Describe)

The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay.

Type of Use (Select one or both, as applicable)

Over-The-Counter Use (21 CFR 801 Subpart C)

(Prescription Use (Part 21 CFR 801 Subpart D)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Yung W. Chan -S

Regulation Number and Section

§ 862.1545 Parathyroid hormone test system.

(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.