Exact One Hematology Analyzer
by Exact Science, Inc. 510(k)
Active
510(k) K900276
Overview
The Exact One Hematology Analyzer is a Counter, Differential Cell, designed for automated hematological analysis. It performs differential cell counting and classification of blood cells, including red blood cells, white blood cells, and platelets, to support diagnostic evaluations in hematology. The device provides quantitative and qualitative measurements essential for assessing blood disorders, infections, and other hematological conditions.
This analyzer is intended for use in clinical laboratory settings and is supplied as a reusable medical device. It operates under regulatory oversight as a Class II device under FDA regulation 864.5220, with a traditional 510(k) clearance (K900276) granted in 1990. The device requires proper maintenance, calibration, and adherence to manufacturer instructions for accurate and reliable performance. No third-party review was involved in its clearance process.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900276 | Date16 Apr 1990 | 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- Withdrawn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
- Full name
- Exact One(Tm) Hematology Analyzer
- 510(k) Number
- FDA Product Code
- GKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Exact One Hematology Analyzer used for?
The Exact One Hematology Analyzer is designed for automated hematological analysis, performing differential cell counting and classification of blood cells. It measures red blood cells, white blood cells, and platelets to help assess blood disorders, infections, and other hematological conditions in clinical laboratory settings. This enables clinicians to make informed diagnostic evaluations based on quantitative and qualitative blood parameters.
Is the Exact One Hematology Analyzer reusable or single-use?
The Exact One Hematology Analyzer is supplied as a reusable medical device. As a reusable instrument, it requires proper maintenance, calibration, and adherence to manufacturer instructions to ensure accurate and reliable performance over time. Regular upkeep is essential to prevent degradation of results and maintain compliance with clinical standards.
What regulatory pathway was followed for the Exact One Hematology Analyzer?
The Exact One Hematology Analyzer was cleared through the FDA’s traditional 510(k) pathway under the classification of a Class II device (regulation number 864.5220). The clearance (K900276) was granted in 1990, with no third-party review involved in the process. This pathway demonstrates that the device was deemed substantially equivalent to a legally marketed predicate device at the time of clearance.
How does the analyzer support hematological diagnostics?
The analyzer provides both quantitative and qualitative measurements of blood cells, which are critical for diagnosing hematological conditions. By automating differential cell counting, it reduces human error and speeds up results, enabling faster identification of abnormalities such as anemia, infections, or platelet disorders. This efficiency is particularly valuable in clinical laboratories where high throughput and accuracy are essential.
What maintenance is required for the Exact One Hematology Analyzer?
The device requires regular maintenance, including calibration and adherence to manufacturer-provided instructions, to ensure consistent and accurate performance. Proper cleaning, servicing, and adherence to operational protocols are necessary to prevent drift in measurements and maintain reliability. Failure to follow these guidelines may compromise diagnostic accuracy and device longevity.