Polymer Technology Systems, Inc. D/B/A Pts Diagnostics
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Polymer Technology Systems, Inc. D/B/A Pts Diagnostics makes
Polymer Technology Systems, Inc. (Pts Diagnostics) manufactures in-vitro diagnostic (IVD) chemistry test kits and automated testing systems for cholesterol and lipid analysis. The PTS Professional Chemistry Kit is designed for laboratory use, while the CardioChek Plus Test System and CardioChek Home Test System provide point-of-care and home testing solutions for measuring key cardiovascular markers like LDL cholesterol, HDL cholesterol, and triglycerides. These devices support clinical and consumer monitoring of lipid profiles to assess cardiovascular risk.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
PTS Professional Chemistry Kit Ref K182781
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, the earliest on 2022-08-16 and the most recent on 2024-09-18. The reasons filed fall into these groups: labeling or instructions for use, packaging, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 18 Sep 2024 Z-0223-2025 Class II Completed The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
2022
- 16 Aug 2022 Z-1741-2022 Class III Completed Incorrect instructions for use were packaged into the final product.
Frequently asked questions
How many devices does Polymer Technology Systems, Inc. D/B/A Pts Diagnostics have in the registry?
The registry currently lists 3 devices for Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polymer Technology Systems, Inc. D/B/A Pts Diagnostics's devices?
Among its 3 most recently registered devices, Polymer Technology Systems, Inc. D/B/A Pts Diagnostics has devices listed in FDA 510(k) (3 devices).
What risk classes do Polymer Technology Systems, Inc. D/B/A Pts Diagnostics's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Polymer Technology Systems, Inc. D/B/A Pts Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Polymer Technology Systems, Inc. D/B/A Pts Diagnostics?
FDA recall records list 2 recalls initiated by Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, the most recent initiated on 2024-09-18. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Polymer Technology Systems, Inc. D/B/A Pts Diagnostics in the registry?
The most recently registered devices listed for Polymer Technology Systems, Inc. D/B/A Pts Diagnostics include PTS Professional Chemistry Kit, CardioChek Plus Test System, CardioChek Home Test System and CardioChek Plus Test System; CardioChek Plus Home Test System.