LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
Device Facts
| Record ID | K132515 |
|---|---|
| Device Name | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS |
| Applicant | DiaSorin, Inc. |
| Product Code | CEW · Clinical Chemistry |
| Decision Date | Nov 8, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1545 |
| Device Class | Class 2 |
Intended Use
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 Story
LIAISON® N-TACT® PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) for quantitative measurement of intact parathyroid hormone (PTH). The device uses a modified two-step, two-site sandwich assay with goat polyclonal antibodies for capture and detection. Input samples (serum, EDTA, or Lithium Heparin plasma) are processed on the LIAISON® XL Analyzer. The system measures light signal via a photomultiplier as relative light units (RLU), which is proportional to intact PTH concentration. Results are calculated using a 2-point calibration conversion of a master curve. The device is used in clinical laboratory settings by trained personnel. Output provides clinicians with quantitative PTH levels to assist in the differential diagnosis of hypercalcemia and hypocalcemia, supporting clinical decision-making regarding calcium metabolism disorders.
Clinical Evidence
Bench testing only. Method comparison study (n=198) against predicate showed Passing & Bablok slope 1.010, intercept -1.5851, r=0.9953. Precision testing (n=160 replicates per sample) showed total %CV ranging from 2.8% to 4.2%. Linearity confirmed across measuring range (3-1900 pg/mL). No high-dose hook effect observed up to 1,000,000 pg/mL. Interference studies showed no significant interference from endogenous substances (e.g., bilirubin, lipids, HAMA) or exogenous drugs.
Technological Characteristics
Chemiluminescent immunoassay (CLIA) using goat polyclonal antibodies. Two-step, two-site sandwich assay principle. Form factor: prepackaged reagents for LIAISON® XL Analyzer. Calibration: 2-point. Measuring range: 3-1900 pg/mL. Traceable to WHO NIBSC 95/646. Standards referenced: CLSI EP5-A2 (precision), EP6-A (linearity), EP7-A2 (interference), EP9-A2-IR (method comparison), EP17-A2 (detection capability), C28-A3 (reference intervals).
Indications for Use
Indicated for the quantitative determination of intact human parathyroid hormone in serum, EDTA, and Lithium Heparin plasma to aid in the differential diagnosis of hypercalcemia and hypocalcemia related to calcium metabolism disorders.
Regulatory Classification
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.
Predicate Devices
- Siemens ADVIA® CENTAUR INTACT Parathyroid Hormone (iPTH) Assay (k020217)
- LIAISON® N-TACT® PTH Control Set (k033426)
- LIAISON® N-TACT® PTH Calibration Verifiers (k093498)
Related Devices
- K033426 — LIAISON N-TACT PTH · DiaSorin, Inc. · Feb 12, 2004
- K150879 — LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers · DiaSorin, Inc. · Jun 22, 2015
- K992105 — IMMULITE TURBO INTACT PTH, MODEL LSKPTZ · Diagnostic Products Corp. · Jul 6, 1999
- K051150 — TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT · Scantibodies Laboratory, Inc. · Jul 26, 2005
Submission Summary (Full Text)
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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
- 2. 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 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.
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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.
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.
#### 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 Device<br>LIAISON® N-TACT® PTH Gen II | Predicate Device<br>ADVIA Centaur iPTH (K020217) |
|-----------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use | For in vitro quantitative determination<br>of intact human parathyroid hormone | For in vitro quantitative determination<br>of 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 serum<br>and Lithium Heparin plasma | EDTA Plasma and Serum |
| Sample size | 150 µL | 200 µL |
| Open storage<br>on 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 Device<br>LIAISON® N-TACT® PTH Gen II<br>Control Set | Predicate Device<br>LIAISON® N-TACT® PTH<br>Control Set (k033426) |
| Intended Use | intended for use as assayed quality<br>control samples to monitor the<br>accuracy and precision of the<br>LIAISON® N-TACT® PTH Gen II | intended for use as assayed quality<br>control samples to monitor the<br>accuracy and precision of the<br>LIAISON® N-TACT® PTH |
| Storage | Store at 2-8°C until ready to use | Same |
| Levels | 2 levels: lyophilized<br>Level 1 (approx 20 pg/mL)<br>Level 2 (approx 300 pg/mL) | 2 levels: lyophilized<br>Level 1 (approx 60 pg/mL)<br>Level 2 (approx 560 pg/mL) |
| Calibration Verifiers Similarities and Differences | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Candidate Device<br>LIAISON® N-TACT® PTH Gen II<br>Calibration Verifiers | Predicate Device<br>LIAISON® N-TACT® PTH<br>Calibration Verifiers (k093498) |
| Intended Use | assayed quality control materials<br>intended for the quantitative<br>verification of calibration and<br>reportable range of the LIAISON®<br>N-TACT® PTH Gen II | assayed quality control materials<br>intended for the quantitative<br>verification of calibration and<br>reportable range of the LIAISON®<br>N-TACT® PTH |
| Storage | 2 to 8°C | Same |
| Levels | 4 levels; lyophilized<br>Cal Ver A (approx 10 pg/mL)<br>Cal Ver B (approx 150 pg/mL)<br>Cal Ver C (approx 650 pg/mL)<br>Cal Ver D (approx 1600 pg/mL) | 4 levels; lyophilized<br>Cal Ver A (approx 20 pg/mL)<br>Cal Ver B (approx 150 pg/mL)<br>Cal Ver C (approx 350 pg/mL)<br>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 | Intercept<br>pg/mL | 95% CI | Correlation<br>coefficient (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 | Intercept<br>pg/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) | Median<br>PTH (pg/mL) | Observed Range<br>2.5th 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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| | | Mean<br>PTH<br>(pg/mL) | Between-Lot | | Total<br>(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 | Spiked<br>Concentration | % Cross<br>Reactivity |
|-----------------------------|-------------------------|-----------------------|
| 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 at<br>which no significant<br>interference (≥ ±10%)<br>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<br>- UE | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>C<br>CUL | LOG |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| < 0.5 pa/mL | 5 pa/mL | 3.0 pg/mL<br>And 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 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.
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
# Yung W. Chan -S
