(281 days)
No
The device description and performance studies focus on a standard chemiluminescence immunoassay technology and do not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) device used for quantitative determination of intact PTH in human serum or plasma to aid in the differential diagnosis of hypercalcemia and hypocalcemia. It provides diagnostic information and does not directly treat or prevent a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma... Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This directly indicates its purpose is for diagnosis.
No
The device is an in vitro diagnostic assay kit that includes physical reagents (magnetic particles, antibodies, calibrators) and is used on an automated system, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma..."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IDS-iSYS Intact PTHN assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
Product codes (comma separated list FDA assigned to the subject device)
CEW
Device Description
The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample.
IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.
IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents:
- Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (1% (w/w%).
- Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%).
The submission is due to a new source of antibody for the assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For in vitro diagnostic use. Rx Only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: The IDS-iSYS Intact PTH" Assay was compared against a commercially available quantitative chemiluminescence Intact PTH assay, following CLSI EP-9A2, "Method Comparison and Bias Estimation Using Patient Samples". A total of 312 serum samples (291 native, 21 spiked), selected to represent a wide range of Intact PTH concentrations [6.3 - 3378.4 pg/mL], was assayed by each method. Deming regression analysis showed a slope of 1.02 and a correlation coefficient (r) of 1.00.
Sample Matrix: The matrix comparison study was performed to evaluate the difference across tube types [serum without additive (red top), serum in separator tubes (SST), and lithium heparin plasma] versus the control samples (K2 EDTA plasma) following the CLSI EP9-A3 guideline. A total of 52 samples (45 native, 7 spiked) matched samples with Intact PTH concentrations ranging from of 10.6 to 2759.0 pg/mL were tested with the IDS-iSYS Intact PTH assay. Passing-Bablok regression analysis showed correlation coefficients (r) of 1.00 for all sample types.
Reference Interval: The 95% reference interval for K2 EDTA plasma samples was calculated from 129 individuals (67 males, 62 females; 21 to 89 years of age) with normal calcium, phosphate, and TSH values from the north, central and south regions of the United States. Reference Interval: 10.3 to 80.5 pg/mL.
Sensitivity: The limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ) were determined with guidance from CLSI EP17-A, "Protocols for Determination of Limits of Detection and Limits of Quantitation" using 60 blanks and 10 low level serum samples. LoB = 0.9 pg/mL, LoD = 2.3 pg/mL, LoQ = 4.5 pg/mL.
Precision: Precision testing was evaluated in accordance with a modified protocol based on CLSI EP-5A2, "Evaluation of Precision Performance of Quantitative Measurement Methods''. Seven (7) samples were assayed using one lot of reagent in duplicate twice per day for 20 days on one System (n=80 for each sample). Total CV% ranged from 1.8% to 9.9%.
Linearity: Linearity was evaluated based on CLSI EP-6A, "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach". For K2 EDTA plasma, Observed = 0.96 x (Expected) = 0.1 pg/mL, R2: 1.00. For serum, Observed = 1.02 x (Expected) = 0.2 pg/mL, R2: 1.00.
High Dose Hook Effect: Testing was conducted up to 100000 pg/mL using 3 samples (1 EDTA Plasma, 2 Serum) spiked with 1-84 PTH, measured in four (4) replicates using 3 reagents lots. No high dose hook effect was observed.
Interferences: Interference studies were performed according to CLSI EP7-A2. Tested substances including Bilirubin, Biotin, Cholesterol, Haemoglobin, HAMA, Rheumatoid Factor, Total Protein, Triglyceride, Acetaminophen, Carbamazepine, and Ibuprofen were found not to interfere significantly based on ≤±10% bias.
Cross Reactivity: Cross-reacting substances studies were performed based on CLSI EP-7A2. PTH (1-84) showed 100% cross-reactivity. PTH (7-84) showed 83.6% cross-reactivity. Other tested substances like PTH (1-34), PTH (39-84), PTH (53-84), PTH (39-68), PTH (44-68), Human Calcitonin, CTX-1, and Osteocalcin showed
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
IMMUNODIAGNOSTIC SYSTEMS LTD MICK HENDERSON REGULATORY AFFAIRS OFFICER 10 DIDCOT WAY BOLDON BUSINESS PARK BOLDON NE35 9PD, GREAT BRITAIN
January 31, 2017
Re: K161158
Trade/Device Name: IDS-iSYS Intact PTH® Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW Dated: January 9, 2017 Received: January 11, 2017
Dear Mick Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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.
Sincerely yours,
Katherine Serrano -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: January 31, 2017
510(k) Number (if known) K161158
Device Name IDS-iSYS Intact PTHN
Indications for Use (Describe)
IDS-iSYS Intact PTHN
The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ||
|---|---|---|---|
| X |
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510(k) SUMMARY IDS-iSYS Intact PTHN Assay
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| 1. | 510(k) Number: | K161158 |
|---|---|---|
| 2. | Submitter: | Immunodiagnostic Systems Ltd |
| 10 Didcot Way | ||
| Boldon Business Park | ||
| Boldon | ||
| Tyne and Wear | ||
| NE35 9PD | ||
| United Kingdom | ||
| 3. | Contact Person: | Mick Henderson |
| Phone: +44(0)191 5190660 | ||
| Fax: +44(0) 191 5190760 | ||
| Email: mick.henderson@idsplc.com | ||
| 4. | Secondary Contact: | Heather Pham |
| Phone: +1(480)-414-7175 | ||
| Fax: +44(0) 191 5190760 | ||
| Email: heather.pham@idsplc.com | ||
| 5. | Date Prepared: | 09 January 2017 |
| 6. | Proprietary and Established Name: | |
| IDS-iSYS Intact PTHN | ||
| 7. | Regulatory Information: | Classification: 21CFR 862.1545 |
| Device Class Class II | ||
| Product Code: CEW | ||
| Panel: Clinical Chemistry (75) |
4
8. Device Descriptions:
The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample.
IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.
IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents:
- · Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (1% (w/w%).
- · Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%).
The submission is due to a new source of antibody for the assay.
5
9. Predicate Devices:
IDS-iSYS Intact PTH, K103325
10. Special Conditions for Use:
For in vitro diagnostic use. Rx Only
11. Special instrument Requirements:
IDS-iSYS Multi-Discipline Automated System (K091849)
12. Intended Use:
The IDS-iSYS Intact PTHN assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
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13. Substantial Equivalence Information
A comparison of the similarities and differences between the modified IDS-iSYS Intact PTH® assay and the original IDS-iSYS Intact PTH assay (K103325) are provided in the following table:
| Assay Similarities and Differences | ||
|---|---|---|
| Characteristics | Predicate Device | |
| IDS-iSYS Intact PTH | ||
| (K103325) | Candidate Device | |
| IDS-iSYS Intact PTHN | ||
| Intended use | intended for the quantitative | |
| determination of PTH in human | ||
| serum or plasma. | Same | |
| Measured analyte | Intact PTH | Same |
| Assay type | Chemiluminescence | |
| immunoassay | Same | |
| Antibody | Goat polyclonal | |
| a) anti- PTH (13-34) | ||
| b) anti-PTH (39-84) | Same | |
| Sample matrix | Plasma (K2-EDTA, | |
| lithium heparin) and | ||
| serum | Same | |
| Sample size | 100 μL | Same |
| Sample | ||
| handling/processing | Automated | |
| IDS-iSYS Multi-Discipline | ||
| Automated System | Same | |
| Calibrator | 2 levels | |
| Included with kit | Same | |
| Calibration interval | 2 point calibration curve stable | |
| for 21 days | 2 point calibration curve stable | |
| for 15 days | ||
| Reagent storage | On-board or at 2-8°C | Same |
| Measurement range | 5 to 5000 pg/mL | 5 to 3500 pg/mL |
| Reference interval | 11.5 to 78.4 pg/mL | 10.3 to 80.5 pg/mL |
| Assay Similarities and Differences | ||
| Characteristics | Predicate Device | |
| IDS-iSYS Intact PTH | ||
| (K103325) | Candidate Device | |
| IDS-iSYS Intact PTHN | ||
| Interfering Substances | ||
| - Bilirubin, conjugated | N/A | 22 mg/dL |
| - Bilirubin, unconjugated | 20 mg/dL | 40 mg/dL |
| - Biotin | 300 nmol/L | Same |
| - Cholesterol | N/A | 395 mg/dL |
| - HAMA | 1000 ng/mL | Same |
| - Hemoglobin | 250 mg/dL | 500 mg/dL |
| - Rheumatoid Factor | 1500 IU/mL | 1836 IU/mL |
| - Total Protein | N/A | 10 g/dL |
| - Triglycerides | 3000 mg/dL | Same |
| - Acetaminophen | N/A | 200 µg/mL |
| - Carbamazepine | N/A | 200 µg/mL |
| - Ibuprofen | N/A | 500 µg/mL |
| Specificity | ||
| - PTH (1-84) | 100% | Same |
| - PTH (7-84) | 60% | 83.9% |
| - PTH (1-34) | 0.5% |