InSure FIT
InSure FIT Sample Kit - NOT FOR SALE Contains 2 Patient Collection Kits, 2 Test Strips, and 1 Run Buffer Bottle
5manufacturers in China registered for this device type
7catalogue numbers in this listing
3510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Enterix Inc., United States |
|---|---|
| FDA product code | KHE |
| Device type | Reagent, Occult Blood |
| Device class | Class 2 |
| Regulation | 21 CFR 864.6550 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K002457 |
| Record published | 2016-09-20 |
| Record revised | 2022-06-10 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from Heat and Direct Sun Light; Storage environment temperature 36 to 77 °F; Storage environment temperature 2 to 25 °C |
| Packaging | Plastic vial of 25, pouch of 200, carton of 10, carton of 25, carton of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01 | In distribution | |
| 01 | In distribution | |
| 01 | In distribution | |
| 01 | In distribution | |
| 01 | In distribution | |
| 01 | In distribution | |
| 01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OC-Light S | Polymedco Cancer Diagnostic Products LLC | 59 |
| McKesson | Mckesson Medical-Surgical Inc. | 21 |
| Hemosure | Hemosure Inc. | 21 |
| Hemoccult | Beckman Coulter, Inc. | 17 |
| Henry Schein | Henry Schein, Inc. | 14 |
| PremierPro | Prestige Ameritech | 11 |
| hema-screen Specific | Immunostics, Inc. | 9 |
| InSure® ONE™ | Enterix Inc. | 8 |
| hema-screen | Immunostics, Inc. | 7 |
| ADS Medical | W.h.p.m., Inc. | 7 |
| QuickVue | Quidel Corp. | 6 |
| Medline | Medline Industries, Inc. | 5 |
Showing 12 of 135. All products under Reagent, Occult Blood
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170548 | 2017-10-05 |
| K060930 | 2006-05-04 |
| K002457 | 2001-01-12 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-09-17 | Class II | Under Investigation by firm | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. | 201,426 test kits | |
| 2020-10-08 | Class II | Under Investigation by firm | Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy | US: 5,256 vials (131,400 test strips); OUS:1051 vials | 2023-01-10 |
| 2008-10-03 | Not classified | Other | False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531–3681. | 45 kits (includes 25 patient collection kits and 1 developer | 2009-03-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.