(199 days)
ST AIA-PACK Intact PTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of the levels of parathyroid hormone in human serum and EDTA plasma on specific TOSOH AIA System analyzers. 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.
The ST AIA-PACK Intact PTH CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK Intact PTH.
The AIA-PACK Intact PTH CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK Intact PTH Assay.
The ST AIA-PACK Intact PTH is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK Intact PTH present in the test sample is bound with polyclonal antibody immobilized on magnetic beads and enzyme-labeled polyclonal antibody in the AIA- PACK. The magnetic beads are washed to remove unbound enzyme-labeled polyclonal antibody and are then incubated with a fluorogenic substrate 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled polyclonal antibody that binds to the beads is directly proportional to Intact PTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The Tosoh Bioscience, Inc.'s ST AIA-PACK Intact PTH Assay is designed for the quantitative measurement of Intact Parathyroid Hormone (Intact PTH) in human serum and EDTA plasma. This device is intended for in vitro diagnostic use for the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" as a separate section with specific numerical targets. However, the performance characteristics presented demonstrate the device's capabilities and its substantial equivalence to the predicate device. For the purpose of this response, reported performance characteristics are presented below in a table format.
| Parameter | Acceptance Criteria (Inferred from Predicate/Performance) | Reported Device Performance (ST AIA-PACK Intact PTH) |
|---|---|---|
| Limit of Detection | Approximately 1.20 pg/ml (Predicate) | ≈1.0 pg/ml |
| Assay Range | Not explicitly stated for predicate in provided text | 1 - 2200 pg/ml |
| Total Precision (CV%) | Not explicitly stated for predicate in provided text | Serum A3: 3.6% |
| Serum B3: 3.7% | ||
| Serum C3: 4.0% | ||
| Plasma A3: 4.9% | ||
| Plasma B3: 4.7% | ||
| Plasma C3: 3.6% | ||
| Correlation (R value) | Not explicitly stated for predicate in provided text | 0.997 (against predicate) |
| Recovery (%) - Mean | Not explicitly stated | ~98.1 - 109.0% range across samples |
| Endogenous Substance Interference | Recovery within ±10% of known mean concentration | Hemoglobin (up to 440 mg/dL), free bilirubin (up to 17 mg/dL), and conjugated bilirubin (up to 17 mg/dL) do not interfere |
| Normal Range | 15 – 65 pg/ml (Predicate) | 8.2 – 83.5 pg/ml |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- Correlation Study: 153 samples were used to establish the correlation with the predicate device.
- Precision Study: For each of the six samples (Serum A3, B3, C3, Plasma A3, B3, C3), multiple measurements would have been taken to calculate the mean, standard deviation, and CV%. The exact number of replicates per sample is not specified, but typically requires a minimum of 20 replicates for precision studies.
- Recovery Study: The report indicates three measurements for each of the six samples (Serum A1, B1, C1, Plasma A1, B1, C1).
- Interference Study: The number of samples for interference testing is not explicitly stated, but it involved testing various concentrations of hemoglobin, free bilirubin, and conjugated bilirubin.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is an in vitro diagnostic device for quantitative measurement, not an AI/radiology imaging device requiring expert ground truth for interpretation. The ground truth for this device is based on analytical measurements and comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set:
Not applicable, for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic imaging device meant to improve human reader performance. It is a standalone in vitro diagnostic assay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the device performance characteristics, such as Limit of Detection, Assay Range, Total Precision, Correlation, Recovery, and Endogenous Substance Interference, are all measures of the device's standalone analytical performance. The study demonstrates the intrinsic performance of the assay without direct human intervention in the measurement process (beyond operating the instrument and preparing samples).
7. Type of Ground Truth Used:
The ground truth for evaluating the ST AIA-PACK Intact PTH assay relied on:
- Analytical Standards/Known Concentrations: For parameters like Limit of Detection, Assay Range, and Recovery, the device's performance is assessed against samples with known, established concentrations of Intact PTH.
- Comparison to a Predicate Device: For the correlation study, the results from the ST AIA-PACK Intact PTH assay were compared to those obtained from the Roche Diagnostics Corp., Elecsys Parathyroid Hormone Test System (K992680), which serves as the "ground truth" or reference method for comparison.
- Interference Testing: Known concentrations of interfering substances added to samples with known Intact PTH levels were used to assess the impact.
8. Sample Size for the Training Set:
Not applicable. This is a biochemical assay, not an AI model that requires a "training set" in the machine learning sense. The device's operational parameters and calibration are established through standard laboratory procedures and physical/chemical principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of developing this type of in vitro diagnostic device. The assay performs measurements based on a chemical reaction and fluorescent detection. Calibration is performed using the ST AIA-PACK Intact PTH CALIBRATOR SET, which would have established values traceable to reference materials.
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Tosoh Bioscience, Inc. K063605
510(k) SUMMARY
JUN 2 1 2007
Submitted By:
Charles P. Gill Tosoh Bioscience, Inc. 3600 Gantz Road Grove City, OH 43123 614-317-1909 Voice 614-317-1941 Fax
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.2.
| Name of Device:Trade Name: | ST AIA-PACK Intact PTH Assay |
|---|---|
| Classification Name: | Parathyroid Hormone Test System |
| Predicate Device: | Roche Diagnostics Corp., Elecsys Parahyroid Hormone TestSystem K992680 |
| Intended Use: | The Tosoh Bioscience, Inc. ST AIA-PACK Intact PTH isdesigned for IN VITRO DIAGNOSTIC USE ONLY for thequantitative measurement of Intact Parathyroid Hormone(Intact PTH) in human serum and EDTA plasma on specificTOSOH AIA System analyzers.The Tosoh AIA-PACK Intact PTH CONTROL SET isintended for IN VITRO DIAGNOSTIC USE ONLY forperforming quality control procedures with the ST AIA-PACKIntact PTH AssayThe Tosoh AIA-PACK Intact PTH CALIBRATOR SET isintended for IN VITRO DIAGNOSTIC USE ONLY for thecalibration of the ST AIA-PACK Intact PTH. |
| Device Description: | The ST AIA-PACK Intact PTH is a two-siteimmunoenzymometric assay which is performed entirely in theAIA-PACK Intact PTH present in the test sample is bound withpolyclonal antibody immobilized on magnetic beads andenzyme-labeled polyclonal antibody in the AIA- PACK. |
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Tosoh Bioscience, Inc.
Performance Characteristics:
| Parameter | Performance Results | |||
|---|---|---|---|---|
| Limit of Detection | ≈1.0 pg/ml | |||
| Assay Range | 1 - 2200 pg/ml | |||
| Total Precision | Sample | Mean(pg/ml) | STDV(pg/ml) | CV% |
| Serum A3 | 27.7 | 1.005 | 3.6 | |
| Serum B3 | 243.6 | 8.936 | 3.7 | |
| Serum C3 | 1123.5 | 44.540 | 4.0 | |
| Plasma A3 | 27.1 | 1.320 | 4.9 | |
| Plasma B3 | 247.1 | 11.497 | 4.7 | |
| Plasma C3 | 1217.2 | 44.159 | 3.6 | |
| Correlation | Number of samples Measured: 153 | |||
| Y = 1.013x - 10.457 | ||||
| R = 0.997 | ||||
| Recovery (Mean ±SD%) | Sample | Percent Recovery (%) | ||
| Serum A1 | 100.3, 103.0, 100.6 | |||
| Serum B1 | 109.0, 103.6, 98.1 | |||
| Serum C1 | 108.5, 107.8, 99.8 | |||
| Plasma A1 | 108.8, 106.0, 104.4 | |||
| Plasma B1 | 108.4, 104.3, 106.4 | |||
| Plasma C1 | 104.2, 105.7, 100.4 | |||
| Endogenous Substance Interferences | Interference is defined to be recovery outside of | |||
| 10% of the known specimen mean concentration. | ||||
| · Hemoglobin (up to 440 mg/dL), free bilirubin | ||||
| (up to 17 mg/dL) and conjugated bilirubin (up | ||||
| to 17 mg/dL) do not interfere with the assay. | ||||
| Sample types | Serum and/or EDTA Plasma | |||
| Reference Ranges | The interval given here was determined in EDTA | |||
| plasma samples. | ||||
| Reference interval = 8.2 - 83.5 pg/mL | ||||
| Sample Range = 9.5 - 98 pg/ml | ||||
Conclusions: This data demonstrates the safety and effectiveness of the ST AIA-PACK Intact PTH Assay for its intended in vitro diagnostic use.
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Tosoh Bioscience, Inc. K063605
The magnetic beads are washed to remove unbound enzyme-labeled polyclonal antibody and are then incubated with a fluorogenic substrate 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled polyclonal antibody that binds to the beads is directly proportional to Intact PTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
Technological Comparison to Predicate:
| Assay /Feature | ST AIA-PACK Intact PTH | Roche Elecsys Intact PTHassay (K992680) |
|---|---|---|
| Analyte | Human Parathyroid Hormone | Human Parathyroid Hormone |
| IntendedUse | The Tosho Bioscience, Inc. ST AIA-PACK Intact PTH is designed for INVITRO DIAGNOSTIC USE ONLY forthe quantitative measurement of IntactParathyroid Hormone (Intact PTH) inhuman serum and EDTA plasma onspecific TOSOH AIA System analyzers. | For the quantitativedetermination of intactparathyroid hormone and fordifferential diagnosis ofhypercalcemia andhypocalcemia. |
| Specimen | EDTA - Plasma | EDTA - Plasma |
| AssayFormat | IEMA | ICMA |
| Result ReadTime | Approximately 20 Minutes | 9 - 18 minutes |
| AnalyticalSensitivity | ≈1.0 pg/ml | ≈ 1.20 pg/ml |
| NormalRange | 8.2 – 83.5 pg/ml | 15 – 65 pg/ml |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract image of an eagle. The eagle is depicted with stylized lines, giving it a modern and symbolic appearance. The text is arranged around the upper half of the circle, while the eagle is positioned in the center.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1 2007
Tosoh Bioscience, Inc. c/o Charles Gill 3600 Gantz Road Grove City, OH 43123
Re: K063605
Trade/Device Name: ST AIA-PACK Intact PTH: ST AIA-PACK Intact PTH CALIBRATOR SET; ST AIA-PACK Intact PTH CONTROL SET Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW, JIT, JJX Dated: June 13, 2007 Received: June 20, 2007
Dear Mr. Gill:
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. Iisting 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
ST AIA-PACK Intact PTH
ST AIA-PACK Intact PTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of the levels of parathyroid hormone in human serum and EDTA plasma on specific TOSOH AIA System analyzers. 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
ST AIA-PACK Intact PTH CALIBRATOR SET
The ST AIA-PACK Intact PTH CALIBRTOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK Intact PTH.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Bensen
Vision Sign-Off
്ffice of In Vitro Diagnostic Device Evaluation and Safety
Page 2 of 3
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Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
The AIA-PACK Intact PTH CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK Intact PTH Assay.
AIA-PACK Intact PTH CONTROL SET
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 2 of 3
§ 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.