BÜHLMANN fCAL® turbo + CALEX® Cap (K191718): FDA 510(k) cleared. For in vitro Diagnostic Use.
CALEX® Cap Extraction- for fecal Calprotectin & fecal Pancreatic Elastase
The BÜHLMANN CALEX® Cap has been introduced to fulfill the requirements of convenient and safe stool extraction. The optimized dilution of stool sample yields maximum extraction efficiency while offering a stability of the calprotectin extracts for up to 3.5 days (84 hours) at 2-8°C, and for pancreatic elastase for up to 12 days at 2-8°C. CALEX® Cap is the first and only stool extraction device suitable for safe air and land transportation according to IATA 650 (UN3373) regulations. The extraction using CALEX® Cap not only offers hygienic stool sampling but also shows very good correlation to gold standard weighing method for stool extraction and is therefore characterized by high reliability.
DESIGN
The design of the CALEX® Cap is fully compatible with automated procedures such as the FDA 510(k) cleared, BÜHLMANN fCAL® turbo, as well as the FDA Exempt BÜHLMANN fPELA® turbo, the random access immunoturbidimetric assays for measuring fecal calprotectin & pancreatic elastase, respectively.
Just like the BÜHLMANN fCAL® turbo, this FDA 510k cleared, fecal calprotectin extraction device is unique in speed, quality, and flexibility.
- Designed for TLA to streamline workflow
- Enhanced ergonometry for automated and manual handling
- Fast and easy stool extraction
- High correlation to gold standard manual extraction
- Optimal dilution offers excellent efficiency in extraction
Delivering Speed, Quality, Flexibility in Stool Pre-analytics
CALEX® Cap is designed to facilitate stool extraction by following 5 simple steps, therefore allowing for fast and reliable stool pre-analytics – the key to reliable results.
Time savings in stool pre-analytics are essential to manage increasing sample volumes.
The fecal calprotectin & pancreatic elastase testing workflow is further simplified when using the CALEX® Cap extraction device, reducing hands on time by ~70%
The CALEX® Cap extraction device combines ease of use and high comparability to the gold standard manual weighing method for the extraction of fecal calprotectin.
A Passing-Bablok regression analysis of 175 patient samples shows an excellent coefficient of correlation of r = 0.932 between the two extraction methods (Fig. 1).
BÜHLMANN fCAL® turbo currently has validated application notes for the Roche c501/502 for use in the U.S. Other major chemistry system validation packages are in process. Please contact BUHLMANN Diagnostics Corp for a complete list of validated applications.
CALEX® Cap is currently FDA 510(k) cleared for use with the BÜHLMANN fCAL® turbo.
Quantum Blue® fCAL is for Research Use Only. Not for use in diagnostic procedures in the US.
CALEX Cap® Tutorial Video
CALEX Cap® on Clinical Analyzer & Track
The BÜHLMANN fCAL® turbo, fPELA® turbo and complimentary CALEX® Cap fecal extraction device, offers total laboratory automation (TLA) for fecal testing. Simplifying the old cumbersome stool pre-analytics procedure to TLA: from Rack Input Module, to Scanning of Barcode, to Load & Unloading the Centrifuge, to Decapping, to Aspiration of Sample, to Resealing with Foil.
Watch this video and see how CALEX® Cap can Streamline Your Workflow!
BÜHLMANN fCAL® turbo Customer Testimonials
View a compilation of BÜHLMANN fCAL® turbo and CALEX® Cap success stories and testimonials. Find valuable highlights, perspectives, advice and details about the successful applications of this fully automated calprotectin assay workflow from each laboratory.
Click here to see a few independent testimonials!
Product Information
| CALEX® Cap | |
| Sample dilution | 1:500 |
| Shelf life | 2-8°C until the expiration date |
| Available pack size | 50 , 200, or 500 |
| Extraction time | <20 minutes |
| Instructions for Use & Other Downloads | see below |
Download IFU and Catalog Numbers‡
View the appropriate tab and click on the blue underlined catalog number to view the Instructions for Use.
Extraction Device:
CALEX® Cap Device – B-CALEX-C50/ B-CALEX-C200/ B-CALEX-C500
Automation:
BÜHLMANN fCAL® turbo – KK-CAL (This kit contains all the components: extraction kit, reagent kit, calibrator kit, and control kit.)
Components: All components below are available for sale separately.
Reagent kit B-KCAL-RSET
Calibrator kit B-KCAL-CASET
Control kit B-KCAL-CONSET
Extraction Kit for BÜHLMANN fCAL® tests: B-CAL-EX3 / B-CAL-EX12 (3 x 125ml or 12 x 125ml)
BÜHLMANN fPELA® turbo – KK-PELA
Components: All components below are available for sale separately.
Reagent kit B‐KPELA‐RSET
Calibrator kit B‐KPELA‐CASET
Control kit B‐KPELA‐CONSET
Extraction Kit for BÜHLMANN fCAL® tests, if not using CALEX® Cap: B-CAL-EX3 / B-CAL-EX12 (3 x 125ml or 12 x 125ml)
BÜHLMANN Products are distributed in Canada by Inter Medico. For more information, email info@inter-medico.com or call 1.800.387.9643.
Extraction Device:
CALEX® Cap Device – B-CALEX-C50/ B-CALEX-C200 / B-CALEX-C500*
* Multilingual [EN, DE, FR, IT, ES]
ELISA:
BÜHLMANN fCAL®ELISA – EK-CAL /CAL2
ELISA Kit Sizes: EK-CAL: 96 wells (1 plate), EK-CAL2: 192 tests (2 plate)
EK-CAL2-WEX 192 tests (without extraction buffer for use with CALEX®)
Automation:
BÜHLMANN fCAL® turbo – KK-CAL
This kit contains all the components: extraction kit, reagent kit, calibrator kit, and control kit.
Components:
All components below are available for sale separately.
Reagent kit: B-KCAL-RSET
Calibrator kit: B-KCAL-CASET
Control kit: B-KCAL-CONSET
Watch Calprotectin Video (CDHF)
BÜHLMANN fPELA® turbo – KK-PELA
Components: All components below are available for sale separately.
Reagent kit B‐KPELA‐RSET
Calibrator kit B‐KPELA‐CASET
Control kit B‐KPELA‐CONSET
Extraction Kit for BÜHLMANN fCAL® tests, if not using CALEX® Cap: B-CAL-EX3 / B-CAL-EX12 (3 x 125ml or 12 x 125ml)
