Home Health Chekup Kit
by Healthkit
510(k) K810488
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810488 | Date8 May 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KHE
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.6550
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Home Health Checkup Kit is a reagent-based diagnostic device designed for the detection of occult blood, classified under hematology. It provides qualitative analysis for fecal occult blood testing, aiding in the early identification of potential gastrointestinal conditions.
This kit is intended for home use and is supplied as a single-use, non-sterile diagnostic tool. It is regulated under FDA 510(k) clearance (K810488) and falls under device class II (regulation number 864.6550). The kit includes multiple reagent components referenced by unique FEI numbers, ensuring compatibility with hematology testing protocols.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Home Health Checkup Kit and how does it function in a clinical setting?
The Home Health Checkup Kit is designed for qualitative analysis of fecal occult blood, helping to detect hidden blood in stool samples. This aids in early identification of potential gastrointestinal conditions, such as colorectal cancer or other digestive issues. It is a reagent-based diagnostic tool intended for home use, allowing individuals to perform testing outside of a clinical environment.
Is the Home Health Checkup Kit sterile, and how is it intended to be used?
The Home Health Checkup Kit is explicitly labeled as non-sterile, meaning it is not intended for invasive procedures or sterile environments. It is supplied as a single-use diagnostic tool, meaning each kit is meant for one-time use only. This ensures accuracy and hygiene for home-based fecal occult blood testing.
How many reagent components are included in the kit, and are they compatible with hematology testing?
The kit includes multiple reagent components, each identified by unique FEI numbers (e.g., 3012516456, 3005174594, etc.). These components are designed for compatibility with hematology testing protocols, ensuring reliable performance for fecal occult blood detection as classified under hematology.
What regulatory pathway was followed for the Home Health Checkup Kit, and what class does it fall under?
The Home Health Checkup Kit was cleared through the FDA 510(k) pathway under the classification K810488, with a substantially equivalent decision (SESE). It is classified as a Class II medical device under regulation number 864.6550, indicating it poses moderate risk and requires specific manufacturing controls.
Are there different sizes or models of the Home Health Checkup Kit, or is it available in a single configuration?
The provided data does not specify distinct sizes or models beyond its core reagent-based design for fecal occult blood testing. The kit is standardized for home use, with all components (including reagents) pre-packaged for single-use. No variations in physical dimensions or configurations are mentioned.