(199 days)
Not Found
No
The device description details a standard immunoenzymometric assay with no mention of AI or ML techniques for data analysis or interpretation. The calculation of unknown sample concentrations is based on a standard curve, a traditional method.
No.
The device is for in vitro diagnostic use only, measuring parathyroid hormone levels to aid in diagnosis, not for direct treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for IN VITRO DIAGNOSTIC USE ONLY" and that "Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia...and hypocalcemia." This directly indicates its role in disease diagnosis.
No
The device is an in vitro diagnostic assay that involves chemical reactions and physical components (magnetic beads, enzyme-labeled antibodies, fluorogenic substrate) to measure a substance in a biological sample. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states multiple times that the device and its associated components are intended for "IN VITRO DIAGNOSTIC USE ONLY". This is the primary indicator that the device falls under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Tosoh Bioscience, Inc. ST AIA-PACK Intact PTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Intact Parathyroid Hormone (Intact PTH) in human serum and EDTA plasma on specific TOSOH AIA System analyzers.
The Tosoh 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 Tosoh AIA-PACK Intact PTH CALIBRATOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the 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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CEW, JIT, JJX
Device Description
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.
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
Not Found
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)
Performance Characteristics:
Limit of Detection: ≈1.0 pg/ml
Assay Range: 1 - 2200 pg/ml
Total Precision:
Serum A3: Mean (pg/ml) 27.7, STDV (pg/ml) 1.005, CV% 3.6
Serum B3: Mean (pg/ml) 243.6, STDV (pg/ml) 8.936, CV% 3.7
Serum C3: Mean (pg/ml) 1123.5, STDV (pg/ml) 44.540, CV% 4.0
Plasma A3: Mean (pg/ml) 27.1, STDV (pg/ml) 1.320, CV% 4.9
Plasma B3: Mean (pg/ml) 247.1, STDV (pg/ml) 11.497, CV% 4.7
Plasma C3: Mean (pg/ml) 1217.2, STDV (pg/ml) 44.159, CV% 3.6
Correlation: Number of samples Measured: 153. Y = 1.013x - 10.457, R = 0.997.
Recovery (Mean ±SD%):
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Roche Diagnostics Corp., Elecsys Parahyroid Hormone Test System K992680
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Test |
| System K992680 | |
| Intended Use: | The Tosoh Bioscience, Inc. ST AIA-PACK Intact PTH is |
| designed for IN VITRO DIAGNOSTIC USE ONLY for the | |
| quantitative measurement of Intact Parathyroid Hormone | |
| (Intact PTH) in human serum and EDTA plasma on specific | |
| TOSOH AIA System analyzers. |
The Tosoh 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 Tosoh AIA-PACK Intact PTH CALIBRATOR SET is
intended for IN VITRO DIAGNOSTIC USE ONLY for the
calibration of the ST AIA-PACK Intact PTH. |
| Device Description: | 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. |
1
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.
2
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 PTH
assay (K992680) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Human Parathyroid Hormone | Human Parathyroid Hormone |
| Intended
Use | The Tosho Bioscience, Inc. ST AIA-
PACK Intact PTH is designed for IN
VITRO DIAGNOSTIC USE ONLY for
the quantitative measurement of Intact
Parathyroid Hormone (Intact PTH) in
human serum and EDTA plasma on
specific TOSOH AIA System analyzers. | For the quantitative
determination of intact
parathyroid hormone and for
differential diagnosis of
hypercalcemia and
hypocalcemia. |
| Specimen | EDTA - Plasma | EDTA - Plasma |
| Assay
Format | IEMA | ICMA |
| Result Read
Time | Approximately 20 Minutes | 9 - 18 minutes |
| Analytical
Sensitivity | ≈1.0 pg/ml | ≈ 1.20 pg/ml |
| Normal
Range | 8.2 – 83.5 pg/ml | 15 – 65 pg/ml |
3
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
5
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
6
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
7
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