SEFRIA™ Hydrocodone Oral Fluid

K252520 · Immunalysis Corporation · DJG · Sep 11, 2025 · Clinical Toxicology

Device Facts

• Record ID: K252520
• Device Name: SEFRIA™ Hydrocodone Oral Fluid
• Applicant: Immunalysis Corporation
• Product Code: DJG · Clinical Toxicology
• Decision Date: Sep 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The assay is intended for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid to be used with clinical analyzers. This assay is calibrated against hydrocodone. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS or LC-MS/MS are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any test result, particularly when preliminary positive results are used.

Device Story

Device is an enzyme immunoassay for detecting hydrocodone in human oral fluid; utilizes Quantisal™ or Quantisal™ II collection devices. Operated by laboratory personnel using automated clinical chemistry analyzers (e.g., Beckman Coulter AU5800). Principle of operation is homogeneous competitive immunoassay. Input is oral fluid specimen; output is qualitative (positive/negative) or semi-quantitative (concentration estimate) result. Semi-quantitative mode assists in determining specimen dilution for confirmatory testing. Results are preliminary; must be confirmed by GC-MS or LC-MS/MS. Clinical decision-making relies on confirmed results; device aids in identifying hydrocodone presence for toxicology screening.

Clinical Evidence

Bench testing only. Precision study (15 days, N=60) established repeatability across 3 lots. Specificity/cross-reactivity evaluated against structurally related and unrelated compounds. Linearity/recovery confirmed 10–100 ng/mL range. Method comparison study (N=80 clinical samples) against LC-MS/MS showed 100% qualitative positive agreement and 92.5% negative agreement; semi-quantitative concordance was 97.5% positive and 95% negative.

Technological Characteristics

Homogeneous competitive enzyme immunoassay. Reagents: antibody and drug conjugate. Cutoff: 30 ng/mL. Instrumentation: automated clinical chemistry analyzer. Storage: 2-8°C. Sample matrix: oral fluid collected via Quantisal™/Quantisal™ II. Calibration: 2-point (qualitative) or 5-point (semi-quantitative) curve, stable up to 14 days.

Indications for Use

Indicated for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid collected via Quantisal™ or Quantisal™ II devices. Intended for use in clinical laboratory settings. Provides preliminary analytical results requiring confirmation by GC-MS or LC-MS/MS.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION MEMORANDUM

510(k) Number: K252520

This 510(k) was reviewed under the OHT7’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.