GEM Premier 4000
by Instrumentation Laboratory CO 2 variants
510(k) K133407
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133407 | Date13 Jan 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CHL
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1120
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The GEM Premier 4000 is an Electrode Measurement Device for Blood-Gases (Pco₂, Po₂) and Blood pH, as classified under FDA code 862.1120. This portable analyzer measures arterial and venous blood gases, electrolytes, and hemoglobin levels, providing critical diagnostic information for clinical chemistry applications in both point-of-care and centralized laboratory settings.
Used in clinical chemistry and critical care environments, the GEM Premier 4000 operates as a single-use electrode-based system for whole blood analysis. Supplied as a modular analyzer with disposable sensors, it requires no special storage conditions beyond standard laboratory environments. The device holds FDA 510(k) clearance (K133407) under a Special Review classification and is intended for use in Class II medical devices, adhering to regulatory standards for blood gas and electrolyte measurement.
Other devices from Instrumentation Laboratory Company
Questions
AI-generated answers, 19 Sep 2026
What types of blood samples can the GEM Premier 4000 analyze, and where is it typically used in a clinical setting?
The GEM Premier 4000 is designed to analyze arterial and venous whole blood samples, measuring critical parameters like blood gases (Pco₂ and Po₂), pH, electrolytes, and hemoglobin levels. It is intended for use in both point-of-care environments, such as emergency rooms or intensive care units, and centralized laboratory settings for clinical chemistry applications, where rapid and accurate diagnostic information is essential for patient care.
How is the GEM Premier 4000 supplied, and are the components reusable or single-use?
The GEM Premier 4000 is supplied as a modular analyzer paired with disposable electrode sensors for whole blood analysis. This design ensures each sensor is intended for single-use only, reducing the risk of cross-contamination and maintaining measurement accuracy. The reusable analyzer itself is built for durability in clinical environments.
What storage conditions are required for the GEM Premier 4000 and its disposable components?
The GEM Premier 4000 analyzer and its disposable sensors do not require any special storage conditions beyond those of a standard laboratory environment. This makes it convenient for use in busy clinical settings where space and temperature control may vary, as long as basic cleanliness and protection from physical damage are maintained.
What regulatory pathway was followed for FDA clearance of the GEM Premier 4000, and what does this mean for its use?
The GEM Premier 4000 received FDA 510(k) clearance under the Special Review classification, classified as substantially equivalent to a predicate device. This means the device was evaluated by the FDA’s Clinical Chemistry Advisory Committee (CH) and determined to meet the regulatory standards for blood gas and electrolyte measurement as a Class II medical device, ensuring its safety and effectiveness for clinical use in measuring arterial and venous blood parameters.