K Number
K231698
Device Name
AllTest Fentanyl Rapid Test (Urine)
Date Cleared
2023-07-31

(49 days)

Product Code
Regulation Number
862.3650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
Device Description
AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
More Information

Not Found

No
The 510(k) summary describes a standard immunoassay for qualitative detection and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

No
The device is an in vitro diagnostic immunoassay that detects fentanyl in urine, providing preliminary results and not directly treating or diagnosing a disease.

Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is for prescription use only."

No

The device description explicitly states it consists of a "Test Cassette" and a "package insert," which are physical components, not software. The device is an immunoassay for detecting fentanyl in urine, which is a chemical test performed on a physical sample using a physical device.

Yes, the provided text explicitly states that the device is an IVD.

Here's the relevant sentence:

"This in vitro diagnostic device is for prescription use only."

N/A

Intended Use / Indications for Use

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

Product codes

DJG

Device Description

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance

  • Precision: Samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off were tested. Each fentanyl concentration was confirmed by LC/MS. All sample aliquots were blindly labeled. For each concentration, tests were performed two tests per day for 10 days per device lot in a randomized order using three lots.
    • Lot 1: -100% (60-/0+), -75% (60-/0+), -50% (60-/0+), -25% (58-/2+), Cutoff (35+/25-), +25% (60+/0-), +50% (60+/0-), +75% (60+/0-), +100% (60+/0-)
    • Lot 2: -100% (60-/0+), -75% (60-/0+), -50% (60-/0+), -25% (59-/1+), Cutoff (28+/32-), +25% (60+/0-), +50% (60+/0-), +75% (60+/0-), +100% (60+/0-)
    • Lot 3: -100% (60-/0+), -75% (60-/0+), -50% (60-/0+), -25% (60-/0+), Cutoff (26+/34-), +25% (60+/0-), +50% (60+/0-), +75% (60+/0-), +100% (60+/0-)
  • Stability: The devices are stable at 2-30 ℃ for 24 months based on real-time stability.
  • Interference: Potential interfering substances were added to drug-free urine and fentanyl urine (at 50% below and 50% above Cut-Off) and tested using three batches. Compounds showing no interference at 100µg/mL or specified concentrations were summarized (list provided in original document).
  • Specificity: Drug metabolites and other components were tested using three batches. The lowest concentration causing a positive result for each compound was listed (table in original document). Negative results for various opioids at 100ug/mL were obtained, indicating no cross-reactivity. Trazodone showed 0.1% cross-reactivity at 1000 ng/mL.
  • Effect of Urine Specific Gravity and Urine pH: Urine samples with specific gravity 1.000 to 1.035 or pH 4 to 9 were spiked with fentanyl at 50% below and 50% above Cut-Off and tested using three lots. Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off.

Comparison Studies

  • Method comparison studies: Performed at three different testing sites. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. Samples were blind labeled and compared to LC/MS results.
    • Site 1: Positive-0 (Negative), 0 (Low Negative), 3 (Near Cutoff Negative), 22 (Near Cutoff Positive), 16 (High Positive). Negative-9 (Negative), 16 (Low Negative), 12 (Near Cutoff Negative), 2 (Near Cutoff Positive), 0 (High Positive).
    • Site 2: Positive-0 (Negative), 0 (Low Negative), 3 (Near Cutoff Negative), 22 (Near Cutoff Positive), 16 (High Positive). Negative-9 (Negative), 16 (Low Negative), 12 (Near Cutoff Negative), 2 (Near Cutoff Positive), 0 (High Positive).
    • Site 3: Positive-0 (Negative), 0 (Low Negative), 2 (Near Cutoff Negative), 21 (Near Cutoff Positive), 16 (High Positive). Negative-9 (Negative), 16 (Low Negative), 13 (Near Cutoff Negative), 3 (Near Cutoff Positive), 0 (High Positive).
  • Discordant Results: Specific samples were identified where the ALLTEST Result differed from the LC-MS/MS Result (tables in original document).

Clinical Studies
Not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found (Performance provided in raw counts as listed above)

Predicate Device(s)

K220046

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Hangzhou AllTest Biotech Co., Ltd. % Joe Shia Director LSI International Inc 504 E Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K231698

Trade/Device Name: AllTest Fentanyl Rapid Test (Urine) Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: June 11, 2023 Received: June 12, 2023

Dear Joe Shia:

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 (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 located 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

1

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. Digitally signed by
Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2023.07.31
12-04-00' Joseph Kotarek, Ph.D. Branch Chief 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

2

Indications for Use

510(k) Number (if known)

K231698

Device Name AllTest Fentanyl Rapid Test (Urine)

Indications for Use (Describe)

AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

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)

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510(k) SUMMARY (K231698)

1. Date:June 11, 2023
2. Submitter:Hangzhou Alltest Biotech Co.,Ltd
#550, Yinhai Street
Hangzhou, zhejiang, China 310018
3. Contact person:Joe Shia
LSI International Inc.
504E Diamond Ave., Suite H
Gaithersburg, MD 20877
Telephone: 240-505-7880
Email: shiajl@yahoo.com
  • AllTest Fentanyl Rapid Test (Urine) 4. Device Names:
Product CodeClassificationRegulation SectionPanel
DJGII21 CFR § 862.3650
Opiate Test SystemToxicology (91)
    1. Predicate Devices:
      Superbio Fentanyl Urine Detection Kit (K220046)
    1. Indications for Use
      AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. This in vitro diagnostic device is for prescription use only.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

    1. Device Description
      AllTest Fentanyl Rapid Test (Urine) is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Rapid Test (Urine) device consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
    1. Substantial Equivalence Information
      A summary comparison of features of the AllTest Fentanyl Rapid Test (Urine) and the predicate devices is provided in following table.
Table 1: Features Comparison of AllTest Fentanyl Rapid Test (Urine) and the Predicate Devices
---------------------------------------------------------------------------------------------------------
ItemDevicePredicate - K220046
-----------------------------------

4

| Indication(s)
for Use | For the qualitative determination of
fentanyl in human urine. | Same |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Calibrator and Cut-Off
Values | Fentanyl (FTY)
1 ng/ml | Same |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription use | Same |
| Configurations | Cassette | Dip Card |
| Platform Required | None | Fluorescence analyzer |
| Storage | 4-30°C | Same |

9. Test Principle

AllTest Fentanyl Rapid Test (Urine) is a competitive and immunochromatography assay, and uses monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine. The test cassette contains fentanyl test strip. The nitrocellulose membrane test area (T) of the test strip is correspondingly coated with fentanyl-bovine serum albumin conjugate, and the quality control area (C) is coated with goat anti-rabbit IgG polyclonal antibody. When the concentration of fentanyl in the sample is higher than or equal to the cut-off of the product, it will compete with the corresponding conjugate coated on the test area (T) to bind to the monoclonal antibody, the test line is inhibited and the result is positive; while when the sample does not contain fentanyl or its concentration is lower than the cut-off of the product, the corresponding conjugate on the test line reacts with sufficient monoclonal antibodies, the test line will be visible and the result is negative. No matter whether the sample contains the corresponding analyte or not, the quality control area (C) will develop a colored line, which is the criteria for judging whether the chromatography process is normal or not.

10. Performance Characteristics

    1. Analytical Performance
    • a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking fentanyl in negative samples. Each fentanyl concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two tests per day for 10 days per device lot in a randomized order.

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cut off | | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |

-----------------------------------------------------------------------------------------------------------------------------------------------------------

5

Lot 160-/0+60-/0+60-/0+58-/2+35+/25-60+/0-60+/0-60+/0-
Lot 260-/0+60-/0+60-/0+59-/1+28+/32-60+/0-60+/0-60+/0-
Lot 360-/0+60-/0+60-/0+60-/0+26+/34-60+/0-60+/0-60+/0-

c. Stability

The devices are stable at 2-30 ℃ for 24 months based on the real time stability.

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drug fentanyl urine with concentrations at 50% below and 50% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL or specified concentrations are summarized in the following tables.

AcetaminophenDoxepinNortriptyline
Acetone (1000mg/dL)Ecgonine methyl esterNoscapine
AcetophenetidinEphedrineO-Hydroxyhippuric acid
Acetylsalicylic acidErythromycinOctopamine
Albumin (100mg/dL)Ethanol (1%)Oxalic acid (100 mg/dL)
AlbuterolFenoprofenOxazepam
AminopyrineFluphenazineOxolinic acid
AmitriptylineFurosemideOxymetazoline
AmobarbitalGalactose (10mg/dL)Papaverine
AmoxicillinGamma Globulin (500mg/dL)Penicillin G
AmpicillinGentisic acidPerphenazine
ApomorphineGlucose (3000mg/dL)Phencyclidine
Ascorbic acidHemoglobinPhenelzine
AspartameHydralazinePhenobarbital
AtropineHydrochlorothiazidePrednisone
Benzilic acidHydrocortisonePropoxyphene (50ug/ml)
Benzoic acidHydroxytyraminePropranolol
BenzoylecgonineIbuprofenPseudoephedrine
BilirubinImipramineQuinine
Boric Acid (1%)IsoproterenolRanitidine
BupropionIsoxsuprineRiboflavin (10mg/dL)
CaffeineKetamineSalicylic acid
CarbamazepineKetoprofenSecobarbital
Chloral hydrateLabetalolSerotonin (5-Hydroxytyramine)
ChloramphenicolLidocaineSulfamethazine
ChlorothiazideLoperamideSulindac
ChlorpromazineMaprotilineTetrahydrocortisone 3-(β-
Dglucuronide)
CholesterolMeperidineTetrahydrocortisone 3-acetate
ClomipramineMeprobamateTetrahydrozoline
ClonidineMethapyrileneThiamine
CortisoneMethaqualoneThioridazine
CotinineMethoxyphenamineTriamterene
CreatinineMetronidazole (300ug/ml)Trifluoperazine
CyclobenzaprineN-AcetylprocainamideTrimethoprim
DeoxycorticosteroneNaCl (4000mg/dL)Tyramine
DesipramineNalidixic acidUrea (2000mg/dL)
DextromethorphanNaloxoneUric acid
DiclofenacNaltrexoneValproic acid (250ug/ml)

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DiflunisalNaproxenVenlafaxine
DigoxinNiacinamideVerapamil
DiphenhydramineNicotineZomepirac
DL-TryptophanNifedipineß-Estradiol
DL-TyrosineNorethindrone

e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of device. The lowest concentration that caused a positive result for each compound are listed below.

| Fentanyl (Cutoff=1ng/mL) | Minimum
concentration required
to obtain a positive
result (ng/mL) | % Cross-Reactivity |
|--------------------------------|-----------------------------------------------------------------------------|--------------------|
| Acetyl fentanyl | 1 | 100 |
| Acrylfentanyl | 1 | 100 |
| ω-1-Hydroxyfentanyl | 20000 | 0.005 |
| Isobutyryl fentanyl | 1 | 100 |
| Ocfentanil | 2.5 | 40.00 |
| Butyryl fentanyl | 2.5 | 40.00 |
| Furanyl fentanyl | 5 | 20.00 |
| Valeryl fentanyl | 10 | 10.00 |
| (±) ß-hydroxythiofentanyl | 2 | 50.00 |
| 4-Fluoro-isobutyrylfentanyl | 50 | 2.00 |
| Para-fluorobutyryl fentanyl | 4 | 25.00 |
| Para-fluoro fentanyl | 3 | 33.33 |
| (±)-3-cis-methyl fentanyl | 50 | 2.00 |
| Carfentanil | 2 | 50.00 |
| Sufentanil | 7.5 | 13.33 |
| Alfentanil | 5000 | 0.02 |
| Despropionyl fentanyl (4-ANPP) | 2500 | 0.04 |
| Remifentanil | >100000 | / |
| Norfentanyl | >100000 | / |
| Acetyl norfentanyl | >100000 | / |
| Norcarfentanil | >100000 | / |

The following opioids compounds were tested at a concentration of 100ug/mL. Negative results were obtained for all these compounds. There is no cross-reactivity for these compounds using the Alltest Fentanyl Rapid Test (Urine).

6-Acetyl morphineNaloxone
AmphetamineNaltrexone
BuprenorphineNorbuprenorphine
BuprenorphineglucuronideNorcodeine
CodeineNorketamine
DextromethorphanNormeperidine
DihydrocodeineNormorphine
EDDPNoroxycodone
EMDPOxycodone

7

FluoxetineOxymorphone
HeroinPentazocine (Talwin)
HydrocodonePipamperone
HydromorphoneRisperidone
KetamineTapentadol
LevorphanolThioridazine
MeperidineTilidine
MethadoneTramadol
MorphineTramadol-O- Desmethyl
Morphine-3-glucuronideTramadol-N- Desmethyl

Trazodone showed 0.1% cross-reactivity as a positive result was observed at 1000 ng/mL.

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target fentanyl at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of device. Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off.

2. Comparison Studies

Method comparison studies for the Alltest Fentanyl Rapid Test (Urine) were performed at three different testing sites. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below.

| | | Negative | Low
Negative by
LC/MS
(less than
-50%) | Near Cutoff
Negative by
LC/MS
(Between
-50% and
cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|-----------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Site
1 | Positive | 0 | 0 | 3 | 22 | 16 |
| Site
1 | Negative | 9 | 16 | 12 | 2 | 0 |
| Site
2 | Positive | 0 | 0 | 3 | 22 | 16 |
| Site
2 | Negative | 9 | 16 | 12 | 2 | 0 |
| Site
3 | Positive | 0 | 0 | 2 | 21 | 16 |
| Site
3 | Negative | 9 | 16 | 13 | 3 | 0 |

Discordant Results

SiteSample NumberLC-MS/MS ResultALLTEST Result
Site 1M411.079Negative
Site 1M400.906Positive
Site 1M21.013Negative
Site 1M580.822Positive
Site 1M590.920Positive
Site 2M141.015Negative
Site 2M21.013Negative
Site 2M630.917Positive
Site 2M590.920Positive

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SiteSample NumberLC-MS/MS ResultALLTEST Result
Site 2M490.842Positive
Site 3M411.079Negative
Site 3M590.920Positive
Site 3M21.013Negative
Site 3M141.015Negative
Site 3M630.917Positive

3. Clinical Studies

Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, and method comparison studies of the devices, it's concluded a substantial equivalence decision.