(31 days)
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.
The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid. The assay is intended for use in laboratories with clinical chemistry analyzers for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid collected with Quantisal™ Oral Fluid Collection Device or Quantisal™ II Oral Fluid collection device.
N/A
FDA 510(k) Clearance Letter - SEFRIA™ Hydrocodone Oral Fluid
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.01
September 11, 2025
Immunalysis Corporation
Shubhajit Mitra
Senior Manager, Regulatory Affairs
829 Towne Center Drive
Pomona, California 91767
Re: K252520
Trade/Device Name: SEFRIA™ Hydrocodone Oral Fluid
Regulation Number: 21 CFR 862.3650
Regulation Name: Opiate test system
Regulatory Class: Class II
Product Code: DJG
Dated: August 8, 2025
Received: August 11, 2025
Dear Shubhajit Mitra:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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K252520 - Shubhajit Mitra Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K252520 - Shubhajit Mitra Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
JOSEPH A. KOTAREK -S
Digitally signed by JOSEPH A. KOTAREK -S
Date: 2025.09.11 07:46:56 -04'00'
Joseph Kotarek
Branch Chief for Toxicology
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K252520
Device Name: SEFRIA™ Hydrocodone Oral Fluid
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary Page 1 of 19
SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay Premarket Notification
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with 21 CFR Section 807.92.
Submitter
510(k) Number: K252520
Applicant Name: Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767
FDA Establishment #: 2020952
Primary Correspondent: Shubhajit Mitra
Senior Manager, Regulatory Affairs
Primary Phone: 508-330-4796
Primary Email: shubhajit.mitra@abbott.com
Alternate Correspondent: Iris Saliba
Director, Regulatory Affairs
Secondary Phone: 619-540-3931
Alternate Email: iris.saliba@abbott.com
Date Prepared: Sep 08, 2025
Page 6
510(k) Summary Page 2 of 19
1. Device Information
Trade or Proprietary Names: SEFRIA™ Hydrocodone Oral Fluid
Common Name: Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay
Device Classification Name: Enzyme Immunoassay, Opiates
Product Codes: DJG
Regulatory Class: Class II
Classification Regulation: 21 CFR 862.3650
Panel: Toxicology (91)
2. Predicate Information
Company: Immunalysis Corporation
Device: SEFRIA™ Oxycodone Oral Fluid Enzyme Immunoassay (K203564)
3. Device Description
The Immunalysis SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is a homogenous enzyme immunoassay with a cutoff of 30 ng/mL in neat oral fluid. The assay is intended for use in laboratories with clinical chemistry analyzers for the qualitative and semi-quantitative analysis of hydrocodone in human oral fluid collected with Quantisal™ Oral Fluid Collection Device or Quantisal™ II Oral Fluid collection device.
4. Indication 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.
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510(k) Summary Page 3 of 19
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. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography- Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Professional judgment should be applied to any test result, particularly when preliminary positive results are used.
5. Comparison to Predicate Device
The subject device has the same design and functionality as the predicate device.
Table 1: Device Comparison
| Device Characteristics | Predicate Device SEFRIA™ Oxycodone Oral Fluid Enzyme Immunoassay (K203564) | Candidate device SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay |
|---|---|---|
| Similarities | ||
| Assay Materials | Ready to use reagents: Antibody reagent, drug conjugate reagent | Same |
| Test Principle | Homogenous, competitive | Same |
| Measurement mode | Qualitative and semi-quantitative | Same |
| Cutoff Level | 30 ng/mL in neat oral fluid | Same |
| Sample matrix | Oral fluid | Same |
| Reagent Storage | 2 - 8°C until expiration date | Same |
| Instrumentation | Automated clinical chemistry analyzer | Same |
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510(k) Summary Page 4 of 19
| Device Characteristics | Predicate Device SEFRIA™ Oxycodone Oral Fluid Enzyme Immunoassay (K203564) | Candidate device SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay |
|---|---|---|
| Mass Spectrometry Confirmation | Required for preliminary positive results | Same |
| Associated oral fluid collection device | Quantisal™ or Quantisal™ II Oral Fluid Collection Device | Same |
| Differences | ||
| Intended Use | Qualitative and semi-quantitative analysis of oxycodone in human oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device | Qualitative and semi-quantitative analysis of hydrocodone in human oral fluid collected by Quantisal™ or Quantisal™ II Oral Fluid Collection Device |
| Target analyte | Oxycodone | Hydrocodone |
6. Performance Characteristics
The following laboratory performance studies were performed to determine substantial equivalence of the SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay to the predicate device. Assay performance was established using the Beckman Coulter AU5800 chemistry analyzer.
6.1 Precision
A precision study was performed over 15 days, 2 runs per day with 2 collection devices per run (N=60), one replicate per collection device on 1 lot of reagent and 3 lots of Quantisal™ Oral Fluid Collection Device. Drug free negative oral fluid was spiked to concentrations of assay cutoff and ±25%, ±50%, ±75%, ±100% of the cutoff and was collected using the collection devices. The spiked concentrations were confirmed by mass spectrometry (LC-MS/MS) before collection. The study established the repeatability of the testing system, including assay and oral fluid collection device. Test results in qualitative and semi-quantitative modes are presented in Table 2 and Table 3.
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510(k) Summary Page 5 of 19
An additional 20-day study was performed on 3 lots of assay reagent to demonstrate the repeatability across multiple reagent lots.
Table 2 – 15 Days Precision -Qualitative- Quantisal™ – All 3 lots
| Concentration (ng/mL) | % of cutoff | # of determinations | Results |
|---|---|---|---|
| Quantisal™ Lot 1 | |||
| 0.0 | -100% | 60 | Negative/100% |
| 7.5 | -75% | 60 | Negative/100% |
| 15 | -50% | 60 | Negative/100% |
| 22.5 | -25% | 60 | Negative/100% |
| 30 | Cutoff | 60 | 27 Positive/33 Negative |
| 37.5 | +25% | 60 | Positive/100% |
| 45 | +50% | 60 | Positive/100% |
| 52.5 | +75% | 60 | Positive/100% |
| 60 | +100% | 60 | Positive/100% |
| Concentration (ng/mL) | % of cutoff | # of determinations | Results |
|---|---|---|---|
| Quantisal™ Lot 2 | |||
| 0.0 | -100% | 60 | Negative/100% |
| 7.5 | -75% | 60 | Negative/100% |
| 15 | -50% | 60 | Negative/100% |
| 22.5 | -25% | 60 | Negative/100% |
| 30 | Cutoff | 60 | 33 positive/27 Negative |
| 37.5 | +25% | 60 | Positive/100% |
| 45 | +50% | 60 | Positive/100% |
| 52.5 | +75% | 60 | Positive/100% |
| 60 | +100% | 60 | Positive/100% |
| Concentration (ng/mL) | % of cutoff | # of determinations | Results |
|---|---|---|---|
| Quantisal™ Lot 3 |
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510(k) Summary Page 6 of 19
| Concentration (ng/mL) | % of cutoff | # of determinations | Results |
|---|---|---|---|
| 0.0 | -100% | 60 | Negative/100% |
| 7.5 | -75% | 60 | Negative/100% |
| 15 | -50% | 60 | Negative/100% |
| 22.5 | -25% | 60 | Negative/100% |
| 30 | Cutoff | 60 | 27 Positive/33 Negative |
| 37.5 | +25% | 60 | Positive/100% |
| 45 | +50% | 60 | Positive/100% |
| 52.5 | +75% | 60 | Positive/100% |
| 60 | +100% | 60 | Positive/100% |
Table 3 - 15 Days Precision -Semi-Quantitative- Quantisal™ – All 3 lots
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| Quantisal™ Lot 1 | |||
| 0.0 | -100% | 60 | Negative/100% |
| 7.5 | -75% | 60 | Negative/100% |
| 15 | -50% | 60 | Negative/100% |
| 22.5 | -25% | 60 | Negative/100% |
| 30 | Cutoff | 60 | 43 Positive/ 17 Negative |
| 37.5 | +25% | 60 | Positive/100% |
| 45 | +50% | 60 | Positive/100% |
| 52.5 | +75% | 60 | Positive/100% |
| 60 | +100% | 60 | Positive/100% |
| Concentration (ng/mL) | % of cutoff | # of determinations | Results |
|---|---|---|---|
| Quantisal™ Lot 2 | |||
| 0.0 | -100% | 60 | Negative/100% |
| 7.5 | -75% | 60 | Negative/100% |
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510(k) Summary Page 7 of 19
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| 15 | -50% | 60 | Negative/100% |
| 22.5 | -25% | 60 | Negative/100% |
| 30 | Cutoff | 60 | 50 positive/10 Negative |
| 37.5 | +25% | 60 | Positive/100% |
| 45 | +50% | 60 | Positive/100% |
| 52.5 | +75% | 60 | Positive/100% |
| 60 | +100% | 60 | Positive/100% |
| Concentration (ng/mL) | % of cutoff | # of determinations | Results |
|---|---|---|---|
| Quantisal™ Lot 3 | |||
| 0.0 | -100% | 60 | Negative/100% |
| 7.5 | -75% | 60 | Negative/100% |
| 15 | -50% | 60 | Negative/100% |
| 22.5 | -25% | 60 | Negative/100% |
| 30 | Cutoff | 60 | 52 Positive/8 Negative |
| 37.5 | +25% | 60 | Positive/100% |
| 45 | +50% | 60 | Positive/100% |
| 52.5 | +75% | 60 | Positive/100% |
| 60 | +100% | 60 | Positive/100% |
6.2 Specificity and Cross Reactivity
Structurally and functionally similar compounds were spiked into drug free pooled oral fluid at levels that will yield a result that is equivalent to the cutoff, if cross reacting. The study verified the cross reactivity of the hydrocodone assay to related drugs and drug metabolites, in both the qualitative and semi-quantitative modes. Cross-reactivity test results in qualitative mode and semi-quantitative mode are presented in Table 4 below.
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510(k) Summary Page 8 of 19
Table 4 – Cross Reactivity – Qualitative and Semi-Quantitative
| Compound | Analyte Conc. (ng/mL) | Hydrocodone Conc. (ng/mL) | Hydrocodone Semi-Quantitative Mean Value (ng/mL) | Hydrocodone Qualitative Result | Cross Reactivity (%) |
|---|---|---|---|---|---|
| 6-Acetylcodeine | 40,000 | 30 | 15.9 | Negative | <0.1% |
| 6-Acetylmorphine | 40,000 | 30 | 18.3 | Negative | <0.1% |
| Buprenorphine | 40,000 | 30 | 4.2 | Negative | <0.1% |
| Dextromethorphan | 40,000 | 30 | 10.7 | Negative | <0.1% |
| Fentanyl | 40,000 | 30 | 5.2 | Negative | <0.1% |
| Heroin | 40,000 | 30 | 11.0 | Negative | <0.1% |
| (+) Methadone | 40,000 | 30 | 5.4 | Negative | <0.1% |
| Morphine-6β-D-Glucuronide | 40,000 | 30 | 4.6 | Negative | <0.1% |
| Norbuprenorphine | 40,000 | 30 | 5.6 | Negative | <0.1% |
| Norcodeine | 40,000 | 30 | 8.6 | Negative | <0.1% |
| Normorphine | 40,000 | 30 | 7.5 | Negative | <0.1% |
| Tapentadol | 40,000 | 30 | 4.8 | Negative | <0.1% |
| Meperidine | 40,000 | 30 | 5.4 | Negative | <0.1% |
| Tramadol | 40,000 | 30 | 5.3 | Negative | <0.1% |
| Codeine | 30,000 | 30 | 30.4 | Positive | 0.1% |
| Levorphanol | 4,000 | 30 | 30.3 | Positive | 0.8% |
| Noroxycodone | 16,500 | 30 | 30.1 | Positive | 0.2% |
| Noroxymorphone | 19,000 | 30 | 30.8 | Positive | 0.2% |
| Oxycodone | 2,000 | 30 | 30.6 | Positive | 1.5% |
| Dihydrocodeine | 1,800 | 30 | 31.2 | Positive | 1.7% |
| Morphine | 32,000 | 30 | 30.9 | Positive | 0.1% |
| Desomorphine | 225 | 30 | 32.9 | Positive | 13.3% |
| Morphine-3β-D-Glucuronide | 19,000 | 30 | 31.0 | Positive | 0.2% |
| Nalorphine | 39,000 | 30 | 31.5 | Positive | 0.1% |
| Norhydrocodone | 1,900 | 30 | 31.3 | Positive | 1.6% |
| Oxymorphone | 2,000 | 30 | 30.8 | Positive | 1.5% |
| Hydromorphone | 34 | 30 | 31.9 | Positive | 88.2% |
| Hydromorphone-3β-D-Glucuronide | 20 | 30 | 31.4 | Positive | 150.0% |
| Naloxone | 2,000 | 30 | 30.4 | Positive | 1.5% |
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510(k) Summary Page 9 of 19
Table 4 – Cross Reactivity – Qualitative and Semi-Quantitative
| Compound | Analyte Conc. (ng/mL) | Hydrocodone Conc. (ng/mL) | Hydrocodone Semi-Quantitative Mean Value (ng/mL) | Hydrocodone Qualitative Result | Cross Reactivity (%) |
|---|---|---|---|---|---|
| 6-Acetylcodeine | 40,000 | 30 | 15.9 | Negative | <0.1% |
| 6-Acetylmorphine | 40,000 | 30 | 18.3 | Negative | <0.1% |
| Buprenorphine | 40,000 | 30 | 4.2 | Negative | <0.1% |
| Dextromethorphan | 40,000 | 30 | 10.7 | Negative | <0.1% |
| Fentanyl | 40,000 | 30 | 5.2 | Negative | <0.1% |
| Heroin | 40,000 | 30 | 11.0 | Negative | <0.1% |
| (+) Methadone | 40,000 | 30 | 5.4 | Negative | <0.1% |
| Morphine-6β-D-Glucuronide | 40,000 | 30 | 4.6 | Negative | <0.1% |
| Norbuprenorphine | 40,000 | 30 | 5.6 | Negative | <0.1% |
| Norcodeine | 40,000 | 30 | 8.6 | Negative | <0.1% |
| Normorphine | 40,000 | 30 | 7.5 | Negative | <0.1% |
| Tapentadol | 40,000 | 30 | 4.8 | Negative | <0.1% |
| Meperidine | 40,000 | 30 | 5.4 | Negative | <0.1% |
| Tramadol | 40,000 | 30 | 5.3 | Negative | <0.1% |
| Codeine | 30,000 | 30 | 30.4 | Positive | 0.1% |
| Levorphanol | 4,000 | 30 | 30.3 | Positive | 0.8% |
| Noroxycodone | 16,500 | 30 | 30.1 | Positive | 0.2% |
| Noroxymorphone | 19,000 | 30 | 30.8 | Positive | 0.2% |
| Oxycodone | 2,000 | 30 | 30.6 | Positive | 1.5% |
| Dihydrocodeine | 1,800 | 30 | 31.2 | Positive | 1.7% |
| Morphine | 32,000 | 30 | 30.9 | Positive | 0.1% |
| Desomorphine | 225 | 30 | 32.9 | Positive | 13.3% |
| Morphine-3β-D-Glucuronide | 19,000 | 30 | 31.0 | Positive | 0.2% |
| Nalorphine | 39,000 | 30 | 31.5 | Positive | 0.1% |
| Norhydrocodone | 1,900 | 30 | 31.3 | Positive | 1.6% |
| Oxymorphone | 2,000 | 30 | 30.8 | Positive | 1.5% |
| Hydromorphone | 34 | 30 | 31.9 | Positive | 88.2% |
| Hydromorphone-3β-D-Glucuronide | 20 | 30 | 31.4 | Positive | 150.0% |
| Naloxone | 2,000 | 30 | 30.4 | Positive | 1.5% |
| Naltrexone | 13,000 | 30 | 31.1 | Positive | 0.2% |
| Oxymorphone-3β-D-Glucuronide | 1,500 | 30 | 31.0 | Positive | 2.0% |
6.3 Interference – Structurally Unrelated Compounds
Structurally unrelated compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free oral fluid containing hydrocodone at ±25% of the cutoff. At the levels tested, there was no interference with structurally unrelated compounds. The concentration levels of structurally unrelated compounds are presented in Table 5.
Table 5 - Non-Interfering Structurally Unrelated Compounds
| Compound | Concentration Tested (ng/mL) |
|---|---|
| 7-Aminoclonazepam | 5,000 |
| 7-Aminoflunitrazepam | 40,000 |
| 7-Aminonitrazepam | 40,000 |
| α-Hydroxyalprazolam | 40,000 |
| Alprazolam | 40,000 |
| Amitriptyline | 40,000 |
| Amobarbital | 40,000 |
| (+)S-Amphetamine | 40,000 |
| Atomoxetine | 40,000 |
| Barbital | 40,000 |
| Benzoylecgonine | 40,000 |
| Benzylpiperazine | 40,000 |
| Bromazepam | 40,000 |
| Brompheniramine | 40,000 |
| Buprenorphine | 40,000 |
| Bupropion | 40,000 |
| Butabarbital | 40,000 |
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510(k) Summary Page 10 of 19
| Compound | Concentration Tested (ng/mL) |
|---|---|
| Butalbital | 40,000 |
| Cannabidiol | 40,000 |
| Cannabinol | 40,000 |
| Carbamazepine | 40,000 |
| Carisoprodol | 40,000 |
| Cetirizine | 40,000 |
| Chlordiazepoxide | 40,000 |
| 1-(3-Chlorophenyl)piperazine (mCPP) | 40,000 |
| Chlorpromazine | 40,000 |
| Chlorpheniramine | 40,000 |
| Cimetidine | 40,000 |
| cis-Tramadol | 40,000 |
| Citalopram | 40,000 |
| Clobazam | 40,000 |
| Clomipramine | 40,000 |
| Clonazepam | 40,000 |
| Clozapine | 20,000 |
| Cocaine | 40,000 |
| Cyclobenzaprine | 40,000 |
| Dehydronorketamine | 10,000 |
| Demoxepam | 40,000 |
| Desalkylflurazepam | 40,000 |
| Desipramine | 40,000 |
| Diazepam | 40,000 |
| Digoxin | 40,000 |
| (±)-10,11-Dihydro-10-Hydroxycarbamazepine | 40,000 |
| Diphenhydramine | 40,000 |
| Doxepin | 40,000 |
| Doxylamine | 40,000 |
| Duloxetine | 40,000 |
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510(k) Summary Page 11 of 19
| Compound | Concentration Tested (ng/mL) |
|---|---|
| Ecgonine | 40,000 |
| Ecgonine Methyl Ester | 40,000 |
| EDDP | 40,000 |
| EMDP | 40,000 |
| 1R,2S(-)-Ephedrine | 40,000 |
| 1S,2R(+)-Ephedrine | 40,000 |
| Ethotoin | 40,000 |
| Ethylmorphine | 5,000 |
| Ethyl-β-D-Glucuronide | 40,000 |
| Fenfluramine | 40,000 |
| Flunitrazepam | 40,000 |
| Fluoxetine | 40,000 |
| Flurazepam | 40,000 |
| Haloperidol | 40,000 |
| Hexobarbital | 40,000 |
| Gabapentin | 40,000 |
| Imipramine | 40,000 |
| Ketamine | 40,000 |
| Lamotrigine | 40,000 |
| Labetalol | 40,000 |
| Lidocaine | 40,000 |
| Lorazepam | 40,000 |
| Lorazepam Glucuronide | 15,000 |
| Loratadine | 40,000 |
| Lormetazepam | 40,000 |
| LSD | 40,000 |
| Maprotiline | 40,000 |
| (±)MDA | 40,000 |
| (±)MDEA | 40,000 |
| (±)MDMA | 40,000 |
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| Compound | Concentration Tested (ng/mL) |
|---|---|
| Meprobamate | 40,000 |
| (+)S-Methamphetamine | 40,000 |
| Methaqualone | 40,000 |
| Methoxetamine | 40,000 |
| Methylone | 40,000 |
| Methylphenidate | 40,000 |
| α-Methyl-α-phenylsuccinimide | 40,000 |
| Mirtazapine | 40,000 |
| Naproxen | 40,000 |
| n-desmethylcitalopram | 40,000 |
| n-desmethyltapentadol | 40,000 |
| Nitrazepam | 40,000 |
| Nordiazepam | 40,000 |
| (±)Norketamine | 40,000 |
| Normesuximide | 40,000 |
| (±)Norpropoxyphene | 40,000 |
| Nortriptyline | 40,000 |
| Olanzapine | 40,000 |
| Oxazepam | 40,000 |
| PCP | 40,000 |
| Pentazocine | 40,000 |
| Pentobarbital | 40,000 |
| Phenazepam | 40,000 |
| Phenobarbital | 40,000 |
| Phentermine | 40,000 |
| (±)Phenylpropanolamine (PPA) | 40,000 |
| Phenytoin | 40,000 |
| PMA | 40,000 |
| PMMA | 40,000 |
| Prazepam | 40,000 |
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| Compound | Concentration Tested (ng/mL) |
|---|---|
| Procaine | 40,000 |
| (±)Propoxyphene | 35,000 |
| Propranolol | 40,000 |
| Protriptyline | 40,000 |
| R(-)-Phenylephrine | 40,000 |
| R,R(-)-Pseudoephedrine | 40,000 |
| Risperidone | 40,000 |
| Ritalinic Acid | 40,000 |
| S,S(+)-Pseudoephedrine | 40,000 |
| Salicylic Acid | 40,000 |
| Secobarbital | 40,000 |
| Sertraline | 40,000 |
| Sufentanil | 40,000 |
| Temazepam | 40,000 |
| (-)11-nor-9-carboxy-Δ9-THC | 40,000 |
| (-)-Δ9-THC | 40,000 |
| (±)-11-hydroxy-Δ9-THC | 40,000 |
| Theophylline | 40,000 |
| Thioridazine | 10,000 |
| Trazodone | 40,000 |
| Triazolam | 40,000 |
| 3-Trifluoromethylphenylpiperazine | 40,000 |
| Trimipramine | 40,000 |
| Tyramine | 40,000 |
| Venlafaxine | 40,000 |
| Verapamil | 40,000 |
| Zolpidem | 40,000 |
| 2-CB(4-bromo-2,5-dimethoxyphenyl-benzeneethamine) | 40,000 |
| Midazolam | 40,000 |
| Oxazepam Glucuronide | 35,000 |
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| Compound | Concentration Tested (ng/mL) |
|---|---|
| Norpseudoephedrine | 7500 |
| O-desmethylvenlafaxine | 40,000 |
| N-desmethylvenlafaxine | 40,000 |
| N-desmethyltramadol | 40,000 |
| O-desmethylcistramadol | 40,000 |
6.4 Interference – Endogenous Compounds and Exogenous Compounds
Endogenous and commonly ingested exogenous compounds were assessed using qualitative and semi-quantitative methods by spiking potential interferents into drug-free oral fluid containing hydrocodone at ±25% of the cutoff concentration. Additionally, oral products were evaluated by collecting oral fluid samples from volunteers using the Quantisal™ Oral Fluid Collection Device after product use. No interference was observed from endogenous substances, exogenous compounds, or orally administered products at the tested levels. Endogenous compounds and exogenous compounds are presented in Table 6, Table 7 and Table 8.
Table 6 – Non-Interfering Endogenous Compounds
| Compound | Concentration Tested |
|---|---|
| Ascorbic Acid | 3 mg/mL |
| Bilirubin | 0.15 mg/mL |
| Cholesterol | 0.45 mg/mL |
| γ-globulin | 0.8 mg/mL |
| Hemoglobin | 3 mg/mL |
| Human Serum Albumin (HSA) | 15 mg/mL |
| IgA | 1 mg/mL |
| IgG | 1 mg/mL |
| IgM | 0.5 mg/mL |
| Salivary-α-amylase | 1000 U/mL |
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510(k) Summary Page 15 of 19
Table 7 – Non-Interfering Exogenous Compounds (Commonly Ingested)
| Compound | Concentration Tested |
|---|---|
| Acetaminophen | 0.05 mg/mL |
| Acetylsalicylic Acid | 0.1 mg/mL |
| Baking Soda | 0.6% v/v |
| Cotinine | 0.03 mg/mL |
| Denture Adhesive | 0.6% w/v |
| Ibuprofen | 0.05 mg/mL |
| Alcohol (Ethanol) | 6% v/v |
| Caffeine | 0.05 mg/mL |
| Coffee | 6% v/v |
| Cranberry Juice | 6% v/v |
| Milk | 2% v/v |
| Mouthwash | 6% v/v |
| Orange Juice | 6% v/v |
| Soft Drink (Pepsi) | 6% v/v |
| Sodium Chloride | 18 mg/mL |
| Tea | 6% v/v |
| Toothpaste | 6% w/v |
| Sugar | 30 mg/mL |
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Table 8 – Non-Interfering Orally Used Exogenous Products
| Product | Quantity Ingested |
|---|---|
| Teeth Whitener | 2 strips |
| Cigarette | 1 cigarette |
| Hard Candy | 1 piece |
| Chewing Gum | 1 piece |
| Sugar | 2 teaspoon |
| Cough Syrup | 2 teaspoon |
| Milk | 100 mL |
| Orange Juice | 100 mL |
| Hydrogen Peroxide (3% OTC) | 10 mL |
| Ibuprofen | 200 mg |
| Acetaminophen | 1000 mg |
6.5 Interference – pH
To evaluate potential interference from the effect of oral fluid pH, device performance in the qualitative and semi-quantitative modes was tested using a range of oral fluid pH values (3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free oral fluid containing hydrocodone at ±25% of the cutoff. At the pH levels tested, there was no interference observed for each test mode.
6.6 Linearity/Recovery
Linearity of the SEFRIA™ Hydrocodone Oral Fluid Immunoassay in semi-quantitative mode was assessed by spiking pooled drug-free oral fluid with a high concentration of hydrocodone. Serial dilutions were performed using drug-free oral fluid to generate specimens with target concentrations ranging from 10 ng/mL to 110 ng/mL. A 0 ng/mL sample was prepared using unspiked drug-free oral fluid. Each concentration level was collected using Quantisal™ Oral Fluid Collection Devices and tested in five replicates. Mean values from replicate testing were used to
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calculate recovery. The assay demonstrated acceptable linearity and recovery across the tested concentration range. Results are summarized in Table 9. The linear range of the assay was confirmed to be 10 – 100 ng/mL using Quantisal™ Oral Fluid Collection Device, and the drug recovery was within the ±15% of the expected value.
Table 9 - Linearity/Recovery – Quantisal
| Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) |
|---|---|---|
| 0 | 4.6 | N/A |
| 10 | 11.3 | 113.2 |
| 20 | 19.7 | 98.6 |
| 30 | 27.5 | 91.5 |
| 40 | 34.4 | 86.1 |
| 50 | 45.3 | 90.7 |
| 60 | 52.9 | 88.2 |
| 70 | 68.7 | 98.1 |
| 80 | 77.7 | 97.1 |
| 90 | 99.6 | 110.6 |
| 100 | 90.9 | 90.9 |
| 110 | 103.6 | 94.2 |
6.7 Hydrocodone Stability in Oral Fluid
The stability of hydrocodone in the oral fluid specimens collected with the Quantisal™ and Quantisal™ II Oral Fluid Collection Device was evaluated with low positive samples (+50% cutoff) at room temperature (8-25°C) and refrigerated (2-8°C). Sample stability testing was performed using LCMS/MS or GC/MS at multiple timepoints post collection at 8°C - 25°C and at 2°C - 8°C. The stability study results demonstrate that oral fluid samples containing hydrocodone are stable at 2°C - 8°C for up to 12 months and 10 days at ambient temperature 8°C - 25°C when stored in
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Quantisal™ or Quantisal™ II Oral Fluid Collection Device. The data to support hydrocodone sample stability was submitted and cleared in K223781 (Quantisal™ II) and K232898 (Quantisal™).
6.8 Calibration Duration
To evaluate calibration stability, drug-free oral fluid samples were spiked with hydrocodone at ±25% of the cutoff concentration and tested in both qualitative and semi-quantitative modes over a 15-day period. At the initial time point, a two-point calibration curve was established in qualitative mode and five-point calibration curve was established in semi-quantitative mode. These calibrations were used through the duration of the study. The test results met acceptance criteria at each time point up to 15 days, providing a validated margin beyond the claimed duration without extrapolation. The calibration duration stability study confirmed that the SEFRIA™ Hydrocodone Oral Fluid Immunoassay supports a calibration interval of up to 14 days.
6.9 Method Comparison
A method comparison study was conducted to evaluate the analytical performance of the SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay using the Beckman Coulter AU5800 analyzer, compared to the reference method, Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). A total of eighty (80) deidentified, unaltered clinical oral fluid samples (40 positive, 40 negative) were tested. Qualitative concordance was 100% for positive samples and 92.5% for negative samples. Semi-quantitative concordance was 97.5% for positives and 95% for negatives. Discordant results were limited and primarily attributed to cross-reactivity or concentrations near the assay cutoff.
Table 10 – Method Comparison
| SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay | LC-MS/MS Hydrocodone Concentration | Agreement (%) |
|---|---|---|
| < 15 ng/mL (Less than -50% cutoff) | 15 to <30 ng/mL (Between -50% cutoff and cutoff) |
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| -50% cutoff) | (Between -50% cutoff and cutoff) | (Between cutoff and +50% cutoff) | than +50% cutoff) | ||
|---|---|---|---|---|---|
| Qualitative | |||||
| Positive | 2 | 1 | 4 | 36 | 100.0 |
| Negative | 34 | 3 | 0 | 0 | 92.5 |
| Semi-Quantitative | |||||
| Positive | 2 | 0 | 3 | 36 | 97.5 |
| Negative | 34 | 4 | 1 | 0 | 95.0 |
Table 11 – SEFRIA™ Hydrocodone Method Comparison Discordant Results
Discordant Result Summary at 30 ng/mL Cutoff
| Sample ID | Concentration (LCMS) | LCMS Qualitative Result | SEFRIA™ Qualitative Result (POS/NEG) | SEFRIA™ Semi-Quantitative Result (POS/NEG) |
|---|---|---|---|---|
| HYC-0319 | 10.3962 | NEG | POS | POS |
| HYC-0324 | 0 | NEG | POS | POS |
| HYC-0327 | 21.996 | NEG | POS | NEG |
| HYC-0355 | 30.4135 | NEG | POS | NEG |
7. Conclusion
The information provided in this pre-market notification demonstrates that the SEFRIA™ Hydrocodone Oral Fluid Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device.
§ 862.3650 Opiate test system.
(a)
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.(b)
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).