Models IDA-2 Plus and IPT-1
by Bio-Tek Instruments, Inc. 510(k)
Active
510(k) K961862
Overview
The Infusion Device Analyzer Models IDA-2 Plus and IPT-1 are diagnostic instruments designed to evaluate and test infusion pumps. These devices assess the accuracy, functionality, and performance of infusion systems, ensuring compliance with operational standards and regulatory requirements. They are classified as Pump, Infusion under FDA coding and are intended for use in clinical or laboratory settings to verify pump calibration and reliability before deployment in patient care.
The IDA-2 Plus and IPT-1 are single-use or reusable diagnostic tools, depending on manufacturer specifications, and are intended for use in general hospital environments. They are not sterile and require proper handling, storage, and maintenance as outlined in the operator’s manual. These devices are FDA-cleared under 510(k) K961862 and fall under Class II regulatory classification (21 CFR 880.5725). They are supplied with specific model identifiers (IDA-2 Plus and IPT-1) and are intended for authorized service personnel only for internal maintenance or calibration.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)ST | NumberK961862 | Date26 Feb 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- ST
Other devices from Bio-Tek Instruments, Inc.
Questions
What are the Bio-Tek IDA-2 Plus and IPT-1 infusion pump analyzers used for?
These devices are diagnostic tools designed to evaluate and test infusion pumps. They assess accuracy, functionality, and performance to ensure compliance with operational standards and regulatory requirements. Clinicians use them in clinical or laboratory settings to verify pump calibration and reliability before deploying the pump in patient care.
Are the IDA-2 Plus and IPT-1 analyzers single-use or reusable?
The usability—whether single-use or reusable—depends on the manufacturer’s specifications for each model. The operator’s manual provides detailed guidance on proper handling, maintenance, and reuse protocols to ensure optimal performance and compliance with safety standards.
Are the Bio-Tek IDA-2 Plus and IPT-1 analyzers sterile?
No, these devices are not sterile. They are intended for use in general hospital environments by authorized service personnel for internal maintenance or calibration. Proper handling, storage, and maintenance as outlined in the operator’s manual are required to prevent contamination.
Who is authorized to use or maintain these infusion pump analyzers?
These devices are intended exclusively for use by authorized service personnel. They are designed for internal maintenance, calibration, and diagnostic testing of infusion pumps, ensuring compliance with regulatory requirements before deployment in patient care.
What regulatory classification and clearance status do the IDA-2 Plus and IPT-1 analyzers hold?
The Bio-Tek IDA-2 Plus and IPT-1 infusion pump analyzers are classified as Class II medical devices under 21 CFR 880.5725 and are FDA-cleared under 510(k) K961862. They are also subject to tracking regulations, ensuring their compliance with stringent safety and performance standards.