(192 days)
Not Found
No
The device description details a standard immunoassay process based on competitive binding and absorbance measurement, with no mention of AI or ML techniques for data analysis or interpretation. The performance studies describe traditional analytical and clinical validation methods.
No.
The device is an in vitro diagnostic assay used for the qualitative determination of methamphetamine in oral fluid, not for treating or preventing disease.
Yes
The device is intended for the qualitative determination of methamphetamine in oral fluid, which is a diagnostic purpose. The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use."
No
The device description clearly outlines a competitive micro-plate immunoassay, which is a laboratory-based test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Device Description: The description details a laboratory-based test ("micro-plate immunoassay") performed on a biological specimen ("oral fluid") to detect a substance ("methamphetamine"). This is the core definition of an in vitro diagnostic test.
- Intended User / Care Setting: The intended user is listed as "Clinical laboratories," which are the typical settings for performing IVD tests.
- Performance Studies: The document describes performance studies conducted to evaluate the device's ability to detect methamphetamine in oral fluid, which is a requirement for IVD devices.
- Predicate Device: The mention of a predicate device (K933052) is common for IVD submissions to regulatory bodies, indicating a comparison to an already approved IVD.
All of these factors strongly indicate that the STC Methamphetamine Intercept™ MICRO-PLATE EIA is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STC Methamphetamine Intercept™ MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of methamphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. For In Vitro Diagnostic Use.
Product codes
LAF
Device Description
The STC Methamphetamine Intercept™ MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of methamphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an EIA well containing an oral fluid specimen positive for methamphetamine, there is a competition between the drug and the enzyme-labeled hapten to bind the antibody fixed onto the EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 mm is inversely proportional to the amount of methamphetamine present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for methamphetamine testing using oral fluid, STC recommends a cutoff of 40 ng/mL when testing oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. This cutoff is within the limit of detection by the STC Methamphetamine Intercept™ MICRO-PLATE EIA.
Anti-Methamphetamine Coated Plate -- Rabbit anti-methamphetamine polyclonal antibody immobilized on a polystyrene plate supplied in dry form.
Methamphetamine Enzyme Conjugate -- Horseradish peroxidase labeled with a
methamphetamine hapten diluted in a protein matrix of bovine serum with protein stabilizers.
Substrate Reagent -- One bottle containing 3,3', 5,5' tetramethylbenzidine.
Stopping Reagent -- Each bottle contains 2 N sulfuric acid.
Oral Fluid Negative Calibrator -- Oral Fluid Diluent negative for methamphetamine.
Oral Fluid Negative Control - Oral Fluid Diluent containing 20 ng/mL (v/v) methamphetamine.
Oral Fluid Cutoff Calibrator -- Oral Fluid Diluent containing 40 ng/mL (v/v) methainphetamine.
Oral Fluid Positive Control - Oral Fluid Diluent containing 80 ng/mL (v/v) methamphetamine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral fluid (collected from gingival mucosa)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories
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)
Non Clinical Data:
Analytical Sensitivity/Limit Of Detection: The Limit of Detection (LOD) was calculated to be 8.0 ng/mL.
Precision: Assessed by testing Oral Fluid Diluent containing 0, 20, 40, 60 and 80 ng/mL methamphetamine. Intra-assay precision determined by analyzing each level 16 times per run for 4 runs. Inter-assay precision determined by analyzing 2 samples at each level twice per day for 20 days.
Results for intra-assay %CV range: 6.2 - 7.8.
Results for inter-assay %CV range: 7.5 - 8.4.
Analytical Specificity/Cross-Reactivity: Cross-reactivity of structurally related compounds calculated at several spiked concentrations in Oral Fluid Diluent. D-Methamphetamine exhibited 100% cross-reactivity. MDMA exhibited 288.471% cross-reactivity. Fenfluramine exhibited 25.917% cross-reactivity.
Effect of Common Materials: Orange Juice (pH effect), Cough Syrup (Pseudoephedrine), Antiseptic (pH effect) were found to affect the assay.
Clinical Data:
A total of 80 matching oral fluid and urine specimens were collected from known or suspected drug abusers. An additional six (6) random oral fluid samples were screened and confirmed for the presence of methamphetamine.
All oral fluid specimens were tested using the STC Methamphetamine Intercept™ MICRO-PLATE EIA. All samples that tested positive and 20 samples that tested negative by EIA were confirmed by GC/MS. All urine samples were screened using a commercial immunoassay kit for amphetamines. Positive samples were confirmed using GC/MS.
For oral fluid testing, a 40 ng/mL cutoff was used for EIA and GC/MS. For urine testing, the cutoffs were 1,000 ng/mL and 500 ng/mL respectively, for the initial screen and GC/MS confirmation based on SAMHSA guidelines.
Agreement of STC Oral Fluid EIA with Urine Assay: 94%. (Matching positive: 20, Matching negative: 54, Mismatched: 3 and 2).
Agreement of STC Oral Fluid EIA with Oral Fluid GC/MS: 98%. (Matching positive: 24, Matching negative: 25, Mismatched: 0 and 1).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement of STC Oral Fluid EIA with Urine Assay: 94%
Agreement of STC Oral Fluid EIA with Oral Fluid GC/MS: 98%
Limit of Detection: 8.0 ng/mL
Intra-assay precision %CV range: 6.2 - 7.8
Inter-assay precision %CV range: 7.5 - 8.4
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.92)
807.92 (a):
| 1. | Submitter's Name: | STC Technologies, Inc. |
|---|---|---|
| Address: | 1745 Eaton Avenue, Bethlehem, PA 18018 | |
| Telephone Number: | (610) 882-1820 | |
| Contact Person: | R. Sam Niedbala, Ph.D., BCFE | |
| Date Prepared: | 02/10/00 |
-
- Device Name: Methamphetamine Intercept™ MICRO-PLATE EIA Proprietary Name: Methamphetamine Intercept™ System Usual Name: Enzyme Immunoassay, Amphetamines Classification Name:
- Device to Which Substantial Equivalence Is Claimed. 3. Roche Diagnostic Systems, Abuscreen ONLINE® kit for amphetamines (urine); K933052
- Description of Device: 4.
Principle of the Assay
The STC Methamphetamine Intercept™ MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of methamphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an EIA well containing an oral fluid specimen positive for methamphetamine, there is a competition between the drug and the enzyme-labeled hapten to bind the antibody fixed onto the EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 mm is inversely proportional to the amount of methamphetamine present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for methamphetamine testing using oral fluid, STC recommends a cutoff of 40 ng/mL when testing oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. This cutoff is within the limit of detection by the STC Methamphetamine Intercept™ MICRO-PLATE EIA.
Anti-Methamphetamine Coated Plate -- Rabbit anti-methamphetamine polyclonal antibody immobilized on a polystyrene plate supplied in dry form.
Methamphetamine Enzyme Conjugate -- Horseradish peroxidase labeled with a
methamphetamine hapten diluted in a protein matrix of bovine serum with protein stabilizers.
Substrate Reagent -- One bottle containing 3,3', 5,5' tetramethylbenzidine.
Stopping Reagent -- Each bottle contains 2 N sulfuric acid.
Oral Fluid Negative Calibrator -- Oral Fluid Diluent negative for methamphetamine.
Oral Fluid Negative Control - Oral Fluid Diluent containing 20 ng/mL (v/v) methamphetamine.
Oral Fluid Cutoff Calibrator -- Oral Fluid Diluent containing 40 ng/mL (v/v) methainphetamine.
Oral Fluid Positive Control - Oral Fluid Diluent containing 80 ng/mL (v/v) methamphetamine.
Principle of the Intercept™ DOA Oral Specimen Collection Device
Saliva is a complex mixture of parotid, submandibular, sublingual and minor salivary gland secretions mixed with mucin, bacteria, leukocytes, sloughed epithelial cells and gingival crevicular fluid. The fact that methamphetamine is present in oral fluid following human use is well documented.
1
The Intercent™ DOA Oral Fluid Collection Device was developed for the purpose of collecting oral fluid for diagnostic testing. The collection device consists of a treated absorbent cotton fiber pad affixed to a nylon stick (Collection Pad) and a preservative solution in a plastic container (Specimen Vial). The Collection Pad is impregnated with a mixture of common salts and gelatin which creates a hypertonic environment and an increased osmotic pressure wherever it contacts oral mucosal cells. The pad is placed in contact with the gingival mucosa (between the lower gum and cheek) which enhances the flow of mucosal transudate across the mucosal surfaces onto the absorptive cotton fibers of the pad. Following the collection period, the Collection Pad is placed into a vial containing a preservative solution which serves to inhibit the growth of oral micro-organisms recovered on the Collection Pad. The vial is sealed with a plastic cap and transported to a laboratory for processing and testing. Following processing, a fluid containing a mixture of saliva components and the preservative solution is recovered which is suitable for testing for the presence of methamphetamine in the Methamphetamine Intercept™ MICRO-PLATE EIA manufactured by STC Technologies, Bethlehem, PA. Refer to the Intercept™ DOA Oral Specimen Collection Device product insert for specific instructions on the proper collection, handling, and adequacy of oral fluid samples.
-
Intended Use Statement: રે.
The STC Methamphetamine Intercept" MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of methamphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. For In Vitro Diagnostic Use. -
- Summary of Technological Characteristics:
The STC Methamphetamine Intercopt™ MICRO-PLATE EIA is based on the principle of solid phase competitive enzyme immunoassay . This application is for the STC Methamphetamine EIA as a screening tool for the detection of methamphetamine using specimens collected with the Intercept™ DOA Oral Specimen Collection Device manufactured by Epitope, Inc., Beaverton, Oregon.
- Summary of Technological Characteristics:
807.92 (b):
- Non Clinical Data: .
Analytical Sensitivity/Limit Of Detection - The Limit of Detection (LOD) was defined from the signal-to-noise ratio at the zero-drug concentration as the mean zero absorbance (An) minus the noise times three (LOD = An - 3SD). The LOD was determined by obtaining the average absorbance value for 80 readings of Oral Fluid Diluent and calculating the standard deviation (SD) and 3SD of the absorbance. The absorbance value minus 3SD was then extrapolated from the curve and represents the sensitivity of the assay. The LOD was calculated to be 8.0 ng/mL.
Precision - The precision of the STC Methamphetamine Intercept™ MICRO-PLATE EIA was assessed by testing Oral Fluid Diluent containing 0, 20, 40, 60 and 80 ng/mL methamphetamine. The intra-assay precision was determined by analyzing each level 16 times per run for 4 runs. Inter-assay precision was determined by analyzing 2 samples at each level twice per day for 20 days. The results of this testing are described in the following table:
| METHAMPHETAMINE
(ng/mL) | MEAN
(O.D.) | MEAN
(%CV) | INTER-ASSAY
(n=4/Bay, 20 days) |
|----------------------------|----------------|---------------|-----------------------------------|
| 0 | 2.056 | 7.8 | 7.5 |
| 20 | 0.978 | 7.0 | 7.7 |
| 40 | 0.710 | 6.2 | 7.9 |
| 60 | 0.554 | 7.8 | 7.5 |
| 80 | 0.480 | 6.4 | 8.4 |
Analytical Specificity/Cross-Reactivity - The analytical specificity of an immunoassay is defined as the cross-reactivity of substances in the assay which are structurally related to the target compound. The percent cross-reactivity of a compound in the STC Methamphetamine Intercept™ MICRO-
2
PLATE EIA is defined as the apparent methamphetamine concentration divided by the spiked concentration times 100.
The cross-reactivities of structurally related compounds were calculated at several spiked concentrations in Oral Fluid Diluent. The following table indicates the apparent concentration of methamphetamine for each substance at a concentration which cross-reacted in the assay. Note: D-Methamphetamine was used as the kit standard and, therefore, will exhibit 100% cross-reactivity.
| β-Phenethylamine | 10,000 | 7.995 | 0.080 |
|---|---|---|---|
| Diphenhydramine | 10,000 | 6.503 | 0.065 |
| D-Amphetamine | 5,000 | 32.160 | 0.643 |
| Fenfluramine | 100 | 25.917 | 25.917 |
| Isoxsuprine | 10,000 | 5.994 | 0.060 |
| 1-Ephedrine | 2,500 | 19.292 | 0.772 |
| 1-Methamphetamine | 1,000 | 2.839 | 0.284 |
| 1-Phenylalanine | 10,000 | 5.343 | 0.053 |
| MDA | 5,000 | 33.817 | 0.676 |
| MDMA | 12.5 | 36.059 | 288.471 |
| Mephentermine | 2,500 | 31.361 | 1.254 |
| Phentermine | 10,000 | 15.935 | 0.159 |
| Phenylephrine | 10,000 | 13.299 | 0.133 |
| Phenylpropanolamine | 10,000 | 9.790 | 0.098 |
| Procaine | 10,000 | 9.917 | 0.099 |
| Pseudoephedrine | 5,000 | 28.748 | 0.575 |
- out of range: not detectable
The user should be aware that the determination of methamphetamine equivalents for each compound is only to calculate the % cross-reactivity of these compounds in the assay. For many of these compounds, the absorbance readings obtained were below the limit of detection of 8.0 ng/mL for the assay. As a result, the % cross-reactivities for these compounds at the levels tested are considered estimates only.
The following compounds were spiked into Oral Fluid Control Matrix at a target concentration of 10,000 ug/mL and tested for cross-reactivity. None were found to produce a signal less than or equal to that of the Oral Fluid Cutoff Calibrator.
| Acetylsalicylic Acid | Cocaethylene | Ibuprofen | Nordiazepam |
|---|---|---|---|
| Alprazolam | Cocaine | Imipramine | Penicillin |
| Amobarbital | Codeine | Lidocaine | Pentobarbital |
| Ampicillin | Cotinine | Medazepam | Phencyclidine |
| Benzoylecgonine | Dextromethorphan | Meperidine | Phenobarbital |
| Butabarbital | Diacetylmorphine | Methadone | Procainamide |
| Butalbital | Fenoprofen | Metoprolol | Quinidine |
| Caffeine | Gemfibrozil | Morphine | Temazepam |
| Chlordiazepoxide | Gentisic Acid | Nalorphine | Theophylline |
| Chlorpromazine | Glipizide | Naproxen | Δ9-THC |
| Clonazepam | Hydrocodone | Niacinamide | Zomepirac |
| Clorazepate | Hydromorphone | Norchlordiazepoxide |
It is possible that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.
2. Clinical Data:
A total of 80 matching oral fluid and urine specimens were collected from known or suspected drug abusers. An additional six (6) random oral fluid samples were screened and confirmed for the presence of methamphetamine. All oral fluid specimens were tested using the STC Methamphetamine Intercept™ MICRO-PLATE EIA. All samples that tested positive and 20 samples
3
that tested negative by EIA were confirmed by GC/MS. All urine samples were screened using a commercial immunoassay kit for amphetamines. Positive samples were confirmed using GC/MS.
For oral fluid testing, a 40 ng/mL cutoff was used for EIA and GC/MS. For urine testing, the cutoffs were 1,000 ng/mL and 500 ng/mL respectively, for the initial screen and GC/MS confirmation based on SAMHSA guidelines.(1) The % agreement of the STC EIA results to the urine EIA and GC/MS results are shown below:
Image /page/3/Figure/2 description: The image shows two tables comparing STC Oral Fluid EIA results with Urine Assay and Oral Fluid GC/MS results. In the first table, with Urine Assay, the agreement is 94%, with values of 20 and 54 for matching positive and negative results, respectively, and 3 and 2 for mismatched results. The second table compares STC Oral Fluid EIA with Oral Fluid GC/MS, showing a 98% agreement, with 24 and 25 for matching positive and negative results, respectively, and 0 and 1 for mismatched results.
3. Conclusions:
A comparison of the performance data for the new device vs. the predicate device is given below:
1. Limit of Detection
| a managar mana mana mana mana mana da maga cagama a mana mana mana mana mana mana mana mana mana man | |
|---|---|
| STC Methamphetamine MICRO-PLATE EIA | 8.0 ng/mL |
| Roche Abuscreen ONLINE® |