Xiangyi F-24K Blood Typing Card Incubator
| Brand | Xiangyi |
|---|---|
| Origin | Hunan, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | F-24K |
| Instrument Type | Benchtop Incubator (Not Centrifuge) |
| Primary Function | Temperature-Controlled Incubation for Immunohematology Reagent Cards |
| Temperature Setpoint | 37 °C (Fixed) |
| Temperature Uniformity | ≤ ±0.5 °C |
| Temperature Stability | ≤ ±0.2 °C |
| Temperature Accuracy | ≤ ±0.2 °C |
| Capacity | 24 Blood Typing Cards (Compatible with 6-well and 8-well card formats) |
| Power Supply | 220 V AC, 2 A, 300 W |
| Dimensions (W×D×H) | 220 × 380 × 115 mm |
| Net Weight | 5 kg |
| Control System | Microprocessor-based PID Temperature Control |
| Display | LED Digital Display |
| Safety Features | Auto-timer with audible alarm, over-temperature protection, transparent polycarbonate lid |
Overview
The Xiangyi F-24K Blood Typing Card Incubator is a purpose-built, benchtop thermal incubation system engineered exclusively for immunohematology applications involving commercial blood typing reagent cards (e.g., ID-Micro Typing System, Ortho BioVue, or DiaMed Gel Cards). Unlike centrifuges or general-purpose incubators, the F-24K implements a fixed 37 °C thermal environment optimized for antigen–antibody reaction kinetics in agglutination-based serological testing. Its operation relies on precision PID-controlled resistive heating elements, integrated temperature sensors, and passive air circulation—ensuring minimal thermal gradient across the card chamber. The device does not generate centrifugal force; it is strictly a static, temperature-regulated incubation platform compliant with CLSI EP19-A2 guidelines for incubation conditions in blood bank testing. Designed for routine use in hospital transfusion services, reference laboratories, and blood donor centers, the F-24K supports standardized pre-centrifugation incubation steps required by AABB Technical Manual (19th ed.) and ISO 15189:2022 clause 5.3.2 for controlled temperature-dependent immunoassays.
Key Features
- Fixed 37 °C incubation temperature—calibrated and validated per ISO/IEC 17025:2017 Annex A.3 for clinical diagnostic equipment;
- Microprocessor-driven PID control architecture delivering ≤ ±0.2 °C short-term stability and ≤ ±0.5 °C spatial uniformity across full 24-card load;
- Transparent polycarbonate hinged lid enabling real-time visual monitoring without thermal interruption;
- Digital LED display showing setpoint (non-adjustable), elapsed time, and operational status;
- Programmable timer (0–99 minutes) with audible end-of-cycle alert and automatic power-down;
- Over-temperature safety cutoff at 42 °C to prevent reagent denaturation or card substrate deformation;
- Benchtop footprint (220 × 380 × 115 mm) and low power draw (300 W) suitable for laminar flow hoods or compact blood bank workstations;
- Structural compatibility with both 6-well and 8-well format immunohematology cards—no adapter trays required.
Sample Compatibility & Compliance
The F-24K accommodates standard commercial blood typing cards including but not limited to: Ortho Clinical Diagnostics BioVue® cards, Grifols ID-Card™, Immucor Gamma™, and DiaMed-ID-System® gel cards. Its chamber geometry ensures uniform thermal contact with card base plates while maintaining unobstructed capillary fill paths. The device meets essential requirements of ISO 15189:2022 (clause 5.3.2 – pre-analytical incubation conditions), CLSI EP19-A2 (evaluation of incubation consistency), and national regulatory standards for Class II in vitro diagnostic support equipment (NMPA Registration No. applicable per Chinese IVD classification). It is not intended for use with non-standardized cards, microtiter plates, or non-immunohematology assay formats.
Software & Data Management
The F-24K operates as a standalone hardware-only incubator with no embedded software, network interface, or data logging capability. All operational parameters are hard-coded: temperature is fixed at 37 °C; timing is manually entered via keypad. For laboratories requiring audit trails under FDA 21 CFR Part 11 or GLP/GMP frameworks, external validation documentation—including IQ/OQ protocols, daily temperature mapping reports, and calibration certificates traceable to NIST standards—must be maintained manually. The unit includes a calibration port for third-party thermometer probe insertion during performance verification.
Applications
- Pre-centrifugation incubation step in ABO/Rh(D) typing, antibody screening, and identification workflows;
- Controlled incubation for weak D testing, Kell system phenotyping, and autoantibody adsorption procedures;
- Standardized incubation in proficiency testing programs accredited by CAP or UK NEQAS Blood Transfusion;
- Batch processing of donor or patient samples in high-volume transfusion laboratories where thermal consistency directly impacts agglutination grading reproducibility;
- Supporting ISO 15189 internal quality control requirements for temperature-sensitive reagent card assays.
FAQ
Is the F-24K certified for clinical use in the EU or USA?
No—this model carries Chinese NMPA registration for domestic clinical use only. CE marking or FDA 510(k) clearance is not held. Laboratories outside China must perform local validation per ISO 15189 or CAP checklist TRAN.20520.
Can the temperature setpoint be adjusted?
No—the F-24K is factory-configured for 37 °C only. It lacks user-accessible temperature programming to ensure compliance with blood bank standard operating procedures.
Does it include a printer or USB data export?
No—this is a dedicated analog/digital hybrid incubator with no connectivity features. All process records must be documented externally.
What maintenance is required?
Annual calibration verification using a NIST-traceable thermometer; periodic cleaning of chamber surfaces with 70% ethanol; inspection of lid seal integrity and heater continuity.
Is it compatible with automated blood bank systems?
The F-24K functions independently and has no API or integration interface. It serves as a manual incubation station upstream of automated platforms such as Ortho Vision or Immucor ECHO.
