K Number

Device Name

STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I

Manufacturer

ORASURE TECHNOLOGIES, INC.

Date Cleared

2000-04-03

(217 days)

Product Code

DKZ

Regulation Number

862.3100

Intended Use

The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of amphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Device Description

More Information

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Device Name

Decision

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Third Party Reviewed

Expedited Review

Predicate Devices

K933052

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies describe a standard immunoassay technology for detecting amphetamine in oral fluid. There is no mention of AI or ML in the document.

Therapeutic

This device is intended for the qualitative determination of amphetamine in oral fluid for diagnostic purposes in clinical laboratories, not for treating or preventing disease.

Diagnostic

Yes

Explanation: The device is intended for the "qualitative determination of amphetamine in oral fluid," which is a diagnostic test to identify the presence of a specific substance in a biological sample. It is explicitly labeled "For In Vitro Diagnostic Use."

SaMD (Software as a Medical Device)

The device description clearly outlines a physical immunoassay kit involving reagents, micro-plates, and a collection device, which are hardware components. The process involves chemical reactions and absorbance measurements, not purely software-based analysis.

IVD (In Vitro Diagnostic)

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."
Nature of the Test: The device performs a test on a biological specimen (oral fluid) outside of the body to determine the presence of a substance (amphetamine). This is the fundamental definition of an in vitro diagnostic test.
Intended User and Setting: The intended user is "clinical laboratories," which are the typical settings for performing IVD tests.

The other information provided, such as the device description, performance studies, and predicate device, further supports that this is an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DKZ

Device Description

The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of amphetamine 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 amphetamine, 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 amphetamine present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for amphetamine testing using oral fluid, STC recommends a cutoff of 100 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 Amphetamine Specific Intercept™ MICRO-PLATE EIA.

KIT COMPONENTS:
Anti-Amphetamine Coated Plate - Mouse anti-amphetamine monoclonal antibody immobilized on a polystyrene plate supplied in dry form.
Enzyme Conjugate -- Horseradish peroxidase labeled with an amphetamine 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 amphetamine.
Oral Fluid Negative Control - Oral Fluid Diluent containing 50 ng/mL (v/v) d-amphetamine.
Oral Fluid Cutoff Calibrator - Oral Fluid Diluent containing 100 ng/mL (v/v) d-amphetamine.
Oral Fluid Positive Control - Oral Fluid Diluent containing 200 ng/mL (v/v) d-amphetamine.

The Intercept™ DOA Oral Specimen 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 hyperonic 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 amphetamine-Specific 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral fluid (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)

Three studies were conducted to determine the clinical accuracy of the STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA.
For oral fluid testing, the cutoffs for EIA and GC/MS were 100 ng/mL and 75 ng/mL, respectively.

Study 1:

Sample size: 1568 oral fluid samples
Data source: randomly screened samples
Key results: 5 specimens presumed positive by EIA were tested by GC/MS. Of these, 3 were positive by GC/MS (95 ng/mL, 115 ng/mL, 381 ng/mL amphetamine). The remaining 2 were negative by GC/MS.

Study 2:

Sample size: 229 individuals
Data source: oral fluid and urine specimen pairs collected from a drug rehabilitation clinic.
Key results: 4 specimen pairs were presumed positive by EIA. These were confirmed positive by GC/MS (691 ng/mL, 7800 ng/mL, and 2500 ng/mL amphetamine).

Study 3:

Sample size: 22 individuals
Data source: two oral fluid specimens and one urine specimen collected from individuals who self-reported use of amphetamines in the past 4 days.
Key results: Of 44 oral fluid samples, 14 samples (92-798 ng/mL amphetamine) were confirmed positive by GC/MS. 26 samples were confirmed negative by GC/MS. 4 samples that were negative by EIA were positive by GC/MS (79 ug/inL, 76 ng/mL, 80 ng/mL, and 125 ng/mL amphetamine).

Combined data from three studies (Oral Fluid GC/MS 75 ng/mL, STC Oral Fluid EIA 100 ng/mL cutoff):
STC Oral Fluid EIA (+) / Oral Fluid GC/MS (+): 21
STC Oral Fluid EIA (+) / Oral Fluid GC/MS (-): 2
STC Oral Fluid EIA (-) / Oral Fluid GC/MS (+): 4
STC Oral Fluid EIA (-) / Oral Fluid GC/MS (-): 26

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

% Agreement = 89% (calculated from combined data as (21+26)/(21+2+4+26) = 47/53 = 88.67%)

Non-Clinical Data:
Analytical Sensitivity/Limit Of Detection (LOD): 25.5 ng/mL.
Precision (Intra-assay % CV): 3.5-6.4
Precision (Inter-assay % CV): 6.7-7.9

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K933052

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).

Summary

3 2000 APR

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:	03/23/00

2.	Device Name:
	Proprietary Name:	Amphetamine-Specific Intercept™ MICRO-PLATE EIA
	Usual Name:	Amphetamine-Specific Intercept™ System
	Classification Name:	Enzyme Immunoassay, Amphetamines

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

KIT COMPONENTS
Anti-Amphetamine Coated Plate - Mouse anti-amphetamine monoclonal antibody immobilized on a polystyrene plate supplied in dry form.
Enzyme Conjugate -- Horseradish peroxidase labeled with an amphetamine 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 amphetamine.
Oral Fluid Negative Control - Oral Fluid Diluent containing 50 ng/mL (v/v) d-amphetamine.
Oral Fluid Cutoff Calibrator - Oral Fluid Diluent containing 100 ng/mL (v/v) d-amphetamine.
Oral Fluid Positive Control - Oral Fluid Diluent containing 200 ng/mL (v/v) d-amphetamine.

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 amphetamine is present in oral fluid following human use is well documented.

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 amphetamine-Specific 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: 5.
The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of amphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. For In Vitro Diagnostic Use.
1. Summary of Technological Characteristics:
  The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is based on the principle of solid phase competitive enzyme immunoassay. This application is for the STC Amphetamine-Specific Intercept™ EIA as a screening tool for the detection of amphetamine using specimens collected with the Intercept™ DOA Oral Specimen Collection Device manufactured by Epitope, Inc., Beaverton, Oregon.

807.92 (b):

1. 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 (Ag) minus the noise times three (LOD = Ao - 3SD). The LOD was determined by obtaining the average absorbance value for 80 readings of blank 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 25.5 ng/mL.

Precision - The precision of the STC Amphetamine-Specific Intercept™ MICRO-PLATE ELA was assessed by testing Oral Fluid Diluent containing 0, 50, 100, 150, and 200 ng/mL amphetamine. 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:

| AMPHETAMINE
(ng/mL) | MEAN O.D. | INTRA-ASSAY
% CV (n=64) | INTER-ASSAY
% CV (n=4/day, 20 days) |
|------------------------|-----------|----------------------------|----------------------------------------|
| 0 | 1.905 | 3.9 | 6.7 |
| 50 | 1.005 | 3.5 | 6.7 |
| 100 | 0.709 | 4.0 | 7.5 |
| 150 | 0.563 | 4.5 | 7.7 |
| 200 | 0.438 | 6.4 | 7.9 |

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 Amphetamine-Specific Intercept™ MICRO-PLATE EIA is defined as the apparent amphetamine concentration divided by the spiked concentration times 100.

The cross-reactivity of structurally related compounds was calculated at several spiked concentrations in Oral Fluid Diluent. The following table indicates the apparent concentration of amphetamine for

each substance at a concentration which cross-reacted in the assay. Note: D-Amphetamine was used as the kit standard and, therefore, will exhibit 100% cross-reactivity.

β-Phenethylamine	100	1.15	1.15
Diphenhydramine	1000	5.05	0.51
d-Methamphetamine	1000	9.07	0.91
Doxylamine	10000	0.06