(217 days)
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay kit and system. There is no mention of AI, ML, or any computational analysis beyond standard statistical methods for performance evaluation.
No.
The device is an in vitro diagnostic device used to measure a biomarker (bone-specific alkaline phosphatase) in human serum, which aids in the management of specific diseases, but it does not directly treat or prevent a disease.
Yes
The first sentence of the "Intended Use / Indications for Use" section explicitly states "The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device".
No
The device description explicitly states it consists of a reagent cartridge and calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP)..."
Furthermore, the "Intended User / Care Setting" section reinforces this by stating: "For in vitro diagnostic use only."
N/A
Intended Use / Indications for Use
The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.
Product codes (comma separated list FDA assigned to the subject device)
CIN
Device Description
The IDS-iSYS Ostase® BAP assay consists of one reagent cartridge and one set of calibrators (CAL A & CAL B).
The reagent cartridge contains multiple reagents:
- MPM1 (Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as preservative);
- Ab-BIOT Monoclonal anti-BAP labelled with biotin, in buffer containing horse serum with bovine and mouse proteins and sodium azide as a preservative (
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 30, 2020
Immunodiagnostic Systems Ltd. Mick Henderson RA Manager 10 Didcot Way, Boldon Business Park Boldon, Tyne and Wear NE35 9PD United Kingdom
Re: K200475
Trade/Device Name: IDS-iSYS Ostase® BAP Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CIN Dated: August 27, 2020 Received: August 31, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
542 of the Act); 21 CFR 1000-1050.
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez- Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200475
Device Name IDS-iSYS Ostase® BAP
Indications for Use (Describe)
The IDS-iSYS Ostase® BAP assay is an in vitro diagnostic device intended for the quantitative determination of bonespecific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of postmenopausal osteoporosis and Paget's disease.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Immunodiagnostic Systems (IDS). The logo features the letters "ids" in a stylized, connected font, with a red circle above the "i". Below the letters, the words "immunodiagnosticsystems" are written in a smaller, red font. A registered trademark symbol is located to the right of the logo.
510(k) SUMMARY
| 510k Number | K200475 |
|---|---|
| Introduction | According to the requirements of 21CFR807.92, the following |
| information provides sufficient detail to understand the basis for a | |
| determination of substantial equivalence. | |
| Submitter | Immunodiagnostic Systems Limited |
| 10 Didcot Way | |
| Boldon Business Park | |
| Boldon | |
| Tyne and Wear | |
| NE35 9PD | |
| United Kingdom | |
| Contact Person: Mick Henderson | |
| Phone: +44 191 5190660 | |
| Fax: +44 191 5190760 | |
| Email: mick.henderson@idsplc.com | |
| Secondary Contact: Alexandra Bennett | |
| Phone: +44 191 5190660 | |
| Fax: +44 191 5190760 | |
| Email: alexandra.bennett@idsplc.com | |
| Date prepared: 28 September 2020 | |
| Device Name | Proprietary names: IDS-iSYS Ostase® BAP |
| Common names: As above | |
| Classification: 21CFR862.1050 Alkaline phosphatase or | |
| isoenzymes test system. | |
| Class II | |
| Product Code: CIN |
4
Image /page/4/Picture/0 description: The image shows the logo for Immunodiagnostic Systems (IDS). The logo features the letters 'ids' in a stylized, interconnected design, with a small red circle above the 'i'. Below the main logo, the words 'immunodiagnosticsystems' are written in a smaller, sans-serif font, with the first word in red and the second in gray. The 'R' in a circle indicates that the logo is a registered trademark.
- Predicate Device The IDS-iSYS Ostase® BAP is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Tandem-MP Ostase Immunoenzymetric Assay (K972666), commercially known as Ostase® BAP EIA.
Device Description The IDS-iSYS Ostase® BAP assay consists of one reagent cartridge and one set of calibrators (CAL A & CAL B).
The reagent cartridge contains multiple reagents:
- MPM1 (Magnetic particles coated with streptavidin in a phosphate buffer with sodium azide as preservative);
- Ab-BIOT Monoclonal anti-BAP labelled with biotin, in buffer containing horse serum with bovine and mouse proteins and sodium azide as a preservative (in vitro device indicated for the
quantitative measurement of bone-
specific alkaline phosphatase
(BAP), an indicator of osteoblastic
activity, in human serum. This
device is intended to be used as an
aid in the management of
postmenopausal osteoporosis and
Paget's disease. | The IDS-iSYS Ostase® BAP
assay is an in vitro diagnostic
device intended for the
quantitative determination of
bone-specific alkaline phosphatase
(BAP), an indicator of osteoblastic
activity, in human serum on the
IDS system. Results are to be used
in conjunction with other clinical
and laboratory data to aid the
clinician in the management of
postmenopausal osteoporosis and
Paget's disease |
| Method of
detection
(Test
methodology) | Manual | Automated |
| Kit reagent
components | Conjugate (1 x 14 mL)
anti-BAP(mouse monoclonal IgG)
with biotin in a bovine/horse protein
matrix with 0.09% sodium azide
Microplates (1 x 96 wells)
Streptavidin coated plastic well
strips
Zero Calibrator (1 x 14 mL)
A bovine protein matrix containing
no detectable concentration of BAP
and 0.09% sodium azide
Calibrators (1-5) (5 x 1 mL)
A bovine protein matrix containing
approximately 7, 15, 30, 60 and 90
ug human BAP/L and 0.09%
sodium azide | Reagent Cartridge
MPM1 (1 x 2.6 mL)
Magnetic particles coated with
streptavidin in a Phosphate buffer
with sodium azide as preservative
(