IL682 Co-Oximeter
by Instrumentation Laboratory CO
510(k) K945677
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945677 | Date20 Oct 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GKR
- Device class
- Class II
- Regulation
- 21 CFR Part 864.5620
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The IL682 Co-Oximeter is an automated system for analyzing hemoglobin components in whole blood. It measures total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin using spectrophotometric principles. This device is classified under automated hemoglobin systems and is primarily used in hematology applications to assess blood oxygenation and detect abnormal hemoglobin fractions.
The IL682 Co-Oximeter operates in clinical laboratory settings and requires whole blood samples of 65 microliters. It accepts capillary tube samples without adapters and is designed for both adult and fetal testing. The system is reusable and intended for single-user operation, with safety features such as automatic shutdown to minimize biohazard exposure. Regulated under FDA 510(k) clearance (K945677) and classified as a Class II device, it adheres to regulatory standards for hematology instruments.
Other devices from Instrumentation Laboratory Company
Questions
AI-generated answers, 1 Oct 2026
What clinical applications does the IL682 Co-Oximeter support?
The IL682 Co-Oximeter is designed for hematology applications to assess blood oxygenation and detect abnormal hemoglobin fractions. It measures total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin, making it useful for evaluating conditions like carbon monoxide poisoning, methemoglobinemia, or fetal hemoglobin analysis.
How is the IL682 Co-Oximeter supplied and what sample type does it require?
The IL682 Co-Oximeter is a reusable, single-user system intended for clinical laboratory use. It analyzes whole blood samples of 65 microliters delivered via capillary tubes—no adapters are required. This design ensures compatibility with standard hematology workflows while minimizing sample waste.
Is the IL682 Co-Oximeter sterile and how should it be stored?
The IL682 Co-Oximeter is not pre-sterilized for single-use; it is a reusable device intended for dedicated clinical laboratory environments. Proper storage involves keeping it in a clean, dry area away from direct sunlight or extreme temperatures to preserve functionality and prevent contamination. Follow manufacturer guidelines for routine maintenance and calibration.
Can the IL682 Co-Oximeter test both adult and fetal blood samples?
Yes, the IL682 Co-Oximeter is explicitly designed for dual use in adult and fetal hematology testing. Its spectrophotometric analysis accommodates the distinct hemoglobin profiles of both populations, including the presence of fetal hemoglobin (HbF) in newborns, making it versatile for pediatric and obstetric applications.
What safety features does the IL682 Co-Oximeter include to reduce biohazard exposure?
The IL682 Co-Oximeter incorporates an automatic shutdown feature to minimize biohazard exposure during operation. This safety mechanism helps prevent accidental contamination or sample spillage, aligning with clinical laboratory protocols for handling blood specimens. The system’s single-user design further reduces cross-contamination risks.