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Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3
Consolidated Technologies
Summary: The QuickCheck Lyophilized Chemistry Control is a quality control device used in laboratory settings to ensure the accuracy of chemical assays. It is primarily used by laboratory technicians and clinicians in diagnostic laboratories.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K981339 ↗
Decision Date ?
April 21, 1998
Product Code ?
JJY
Device Class ?
Class 1
Evidence ?
419 studies
The QuickCheck Lyophilized Chemistry Control was cleared through the FDA 510k pathway on April 21, 1998. Manufactured by Consolidated Technologies, it is classified as a Class 1 device under product code JJY.
What It Is
The QuickCheck Lyophilized Chemistry Control is a laboratory device used to verify the accuracy and precision of chemical assays. It comes in a lyophilized form, which requires reconstitution before use. This control is crucial for maintaining the reliability of laboratory results, ensuring that diagnostic tests provide accurate data for patient care.
FDA-Cleared Indications
- For use as a quality-control material for chemical assays.
- For monitoring the performance and reliability of clinical chemistry testing systems.
- For use in clinical laboratory settings according to the manufacturer's instructions.
Clinical Applications
- Checking the accuracy of chemical assay results before patient results are reported.
- Monitoring assay precision and detecting changes in laboratory test performance.
- Evaluating the performance of compatible clinical chemistry analyzers.
- Supporting routine quality-control procedures in hospital and diagnostic laboratories.
Practical Considerations
- The lyophilized material must be reconstituted with the specified volume and type of water before testing.
- Use only with assays and chemistry analyzers listed as compatible by the manufacturer.
- Follow the manufacturer's instructions for storage, handling, expiration, mixing and stability after reconstitution.
- This is an in-vitro laboratory control, not a device placed in or used on a patient.
- MRI safety labeling is generally not applicable because the product is not an implant or patient-use device.
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 QuickCheck Lyophilized Chemistry Control used for?
It is used as a quality control measure in laboratories to ensure the accuracy and precision of chemical assays.
What specialties typically use this device?
Clinical chemistry laboratories, hospital diagnostic labs, and any setting where biochemical assays are performed.
What are the FDA-cleared indications?
The device is indicated for use as a quality control in chemical assays to ensure accurate laboratory results.
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.