đź“‹ FDA Reference
Biotis Haemophilus Identification Quad
Otisville Biotech
Summary: The biotis haemophilus identification quad is a diagnostic tool used to identify Haemophilus species. It is primarily used by microbiologists and laboratory technicians in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K862387 ↗
Decision Date ?
July 3, 1986
Product Code ?
JSH
Device Class ?
Class 1
Evidence ?
419 studies
The biotis haemophilus identification quad was cleared through the FDA 510k pathway on July 3, 1986. Manufactured by Otisville Biotech, it is classified as a Class 1 device under product code JSH.
What It Is
The biotis haemophilus identification quad is a laboratory diagnostic device designed to identify various species of the Haemophilus genus. It works by utilizing specific biochemical reactions that are characteristic of these bacteria. This device aids in the rapid and accurate identification of Haemophilus species, which is crucial for diagnosing infections and guiding appropriate treatment.
FDA-Cleared Indications
- For the in vitro identification of Haemophilus species from clinical specimens.
- For use by qualified laboratory personnel in clinical microbiology testing.
- The FDA record identifies the device under product code JSH and a 510(k) clearance from 1986.
Clinical Applications
- Identifying Haemophilus recovered from respiratory specimens.
- Identifying Haemophilus recovered from blood cultures or other clinical specimens.
- Supporting laboratory diagnosis of suspected Haemophilus infection.
- Providing organism identification to help clinicians select appropriate antimicrobial treatment.
Practical Considerations
- This is an in vitro laboratory device, not an implant or treatment delivered to a patient.
- Use requires appropriate specimen collection, transport, culture, and handling procedures.
- Testing should be performed by trained microbiology personnel according to the manufacturer’s instructions and laboratory quality-control procedures.
- The device is not an MRI-related product and has no MRI safety classification or implant-size specifications.
- Results should be interpreted with the clinical findings and other laboratory testing; organism identification alone does not establish the severity or site of infection.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is biotis haemophilus identification quad used for?
It is used for identifying Haemophilus species in clinical specimens, aiding in the diagnosis of infections.
What specialties typically use this device?
Microbiologists and laboratory technicians in infectious disease and pediatric specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for identifying Haemophilus species in clinical specimens to assist in diagnosing infections.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.