(39 days)
OraSure®
No
The device description and performance studies describe a standard immunoassay technology, not AI/ML. There are no mentions of AI, DNN, or ML in the provided text.
No.
This device is an in vitro diagnostic (IVD) test intended for the qualitative determination of opiates in oral fluid, which is used for diagnostic purposes (detection of a substance) rather than for treating or preventing a disease or condition.
Yes
The device is intended for the "qualitative determination of opiates in oral fluid," which is a diagnostic purpose to identify the presence of substances in a patient's sample. The phrase "For In Vitro Diagnostic Use" directly confirms its diagnostic nature.
No
The device is a micro-plate immunoassay, which is a laboratory test method involving physical components (micro-plates, reagents, etc.) and is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use." This is the primary indicator that the device is intended for use in diagnosing conditions or diseases based on tests performed on samples taken from the human body, but not within the body itself.
Furthermore, the device description and performance studies detail its use in testing oral fluid samples in a laboratory setting to detect the presence of opiates, which aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STC Opiates Micro-Plate EIA is intended for use in the qualitative determination of opiates in oral fluid collected with the OraSure Specimen Collection Device. For In Vitro Diagnostic Use.
Product codes
DJG
Device Description
The STC Opiates EIA is a competitive micro-plate immunoassay for the detection of opiates in oral fluid collected with the OraSure® 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 OraSure® specimen positive for opiates, there is a competition between the drug and the enzyme-labeled hapten to bind the antibody fixed onto the EIA well. EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 nm is inversely proportional to the amount of opiates present in the specimen or calibrator/control, Because currently there are no SAMHSA assigned cutoffs for opiates testing using oral fluid, STC recommends a cutoff of 10 ng/mL when testing oral fluid collected with the OraSure® Oral Specimen Collection Device. This cutoff is within the limit of detection by the STC Opiates Micro-Plate EIA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral fluid
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)
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 (Ao) minus the noise times three (LOD = Ao - 3SD). The LOD was determined by obtaining the absorbance value for twelve blank OraSure® devices and calculating the standard deviation (SD) of the absorbance values. The absorbance value minus 3SD was then extrapolated from the curve and represents the sensitivity of the assay. The LOD was calculated to be 0.2 ng/mL.
Precision
The precision of the STC Opiates Micro-Plate EIA was assessed by testing OraSure® Control Matrix containing 0, 5, 10, or 20 ng/mL morphine. 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 intra-assay % CV range for STC Opiates Micro-Plate EIA (OraSure®) was 8-17.
The inter-assay % CV range for STC Opiates Micro-Plate EIA (OraSure®) was 9-13.
Analytical Specificity/Cross-Reactivity
The percent cross-reactivity of a compound in the STC Opiates Micro-Plate EIA is defined as the apparent morphine concentration divided by the spiked concentration times 100.
The cross-reactivity of structurally related compounds was calculated at several spiked concentrations in normal human urine.
Examples of cross-reactivity:
- 6-Acetylmorphine: 14% at 100 ng/mL
- Codeine: >100% at 10 ng/mL
- Diacetylmorphine: >100% at 5 ng/mL
- Hydrocodone: >100% at 5 ng/mL
- Morphine: 100% at 10 ng/mL
Compounds tested at 10,000 ng/mL in OraSure® Control Matrix and found not to cross-react (signal less than or equal to Opiates Cutoff Calibrator) include: Acetylsalicylic Acid, Alprazolam, Amobarbital, Ampicillin, β-Phenethylamine, Benzoylecgonine, Butabarbital, Butalbital, Caffeine, Chlordiazepoxide, Chlorpromazine, Clonazepam, Clorazepate, Cocaethylene, Cocaine, Cotinine, D-Amphetamine, D-Methamphetamine, Fenoprofen, Gemfibrozil, Gentisic Acid, Glipizide, Ibuprofen, Imipramine, L-Ephedrine, L-Methamphetamine, Lidocaine, Medazepam, Methadone, Metroprolol, Naproxen, Niacinamide, Norchlordiazepoxide, Nordiazepam, PCP, Penicillin, Pentobarbital, Phenobarbital, Phenylephrine, Phenylpropanolamine, Procainamide, Procaine, Pseudoephedrine, Quinidine, Temazepam, Δ9-THC, Theophylline, Zomepirac.
Clinical Data
Accuracy
The clinical sensitivity and specificity of the STC Micro-Plate assay were determined by testing specimens from chronic opiate users. A controlled dose study was also conducted. The cutoffs for EIA and GC/MS were 10 ng/mL and 15 ng/mL, respectively, for OraSure® specimens. For urine specimens, the EIA cutoff was 300 ng/mL and the GC/MS cutoff was 150 ng/mL.
Study 1 - Chronic Opiates Users
Matched urine and OraSure® specimens were collected from ten (10) self-reported opiates users and fifty (50) presumed negative samples. All sixty (60) samples were tested in the STC Opiates Micro-Plate EIA and presumed positives (10) were also tested by gas chromatography/mass spectrometry (GC/MS).
Of the 10 samples presumed positive, the % sensitivity and % specificity of the OraSure® STC EIA as compared to GC/MS were 100.0% and 87.5%, respectively.
For urine STC EIA, the % sensitivity and % specificity of the urine STC EIA as compared to GC/MS were 87.5% and 100.0% respectively.
Study 2 - Controlled Dose Study
A total of 5 volunteers in a controlled environment were administered an initial 3 mg of intravenous heroin HCl, followed by a second 6 mg or 12 mg heroin dose 4 to 12 days later. Saliva and urine samples were collected before dosing and periodically for up to 74 hours after dosing. Saliva specimens (400 uL) were added to the collection pad of the OraSure Oral Fluid Collection Device and processed according to the package insert. Samples were then tested using the STC assay and GC/MS.
Using a 10 ng/mL cutoff for OraSure® samples, opiates were detectable by EIA for up to 2 hours after a 12 mg heroin dose and not detectable at any time for a 3 or 6 mg dose. Of the GC/MS saliva results, only the initial post-12 mg dose samples contained drug concentrations above the 15 ng/mL LOD/LOQ. This demonstrates the ability of the STC EIA to detect opiate concentrations at intravenous doses as low as 12 mg heroin HCl. The ability of the kit to detect opiates at doses between 6 mg-12 mg is unknown.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LOD: 0.2 ng/mL (OraSure®)
Intra-assay precision %CV: 8-17 (OraSure®)
Inter-assay precision %CV: 9-13 (OraSure®)
OraSure® STC EIA vs. GC/MS sensitivity (Study 1): 100.0%
OraSure® STC EIA vs. GC/MS specificity (Study 1): 87.5%
Urine STC EIA vs. GC/MS sensitivity (Study 1): 87.5%
Urine STC EIA vs. GC/MS specificity (Study 1): 100.0%
Predicate Device(s)
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
K98134|
MAY 2 2 1998
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.92)
807.92 (a):
- STC Technologies, Inc. 1. Submitter's Name: 1745 Eaton Avenue, Bethlehem, PA 18018 Address: (610) 882-1820 Telephone Number: R. Sam Niedbala, Ph.D., BCFE Contact Person: April 8, 1998 Date Prepared:
- Device Name: 2. Opiates Micro-Plate EIA (OraSure® Application) Proprietary Name: Usual Name: Opiates EIA Enzyme Immunoassay, Opiates Classification Name:
- Device to Which Substantial Equivalence Is Claimed: 3. STC Opiates Micro-Plate EIA (Urine); K924446
- Description of Device: 4.
Principle of the Assay
The STC Opiates EIA is a competitive micro-plate immunoassay for the detection of opiates in oral fluid collected with the OraSure® 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 OraSure® specimen positive for opiates, there is a competition between the drug and the enzyme-labeled hapten to bind the antibody fixed onto the EIA well. EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 nm is inversely proportional to the amount of opiates present in the specimen or calibrator/control, Because currently there are no SAMHSA assigned cutoffs for opiates testing using oral fluid, STC recommends a cutoff of 10 ng/mL when testing oral fluid collected with the OraSure® Oral Specimen Collection Device. This cutoff is within the limit of detection by the STC Opiates Micro-Plate EIA.
1
| KIT COMPONENTS |
|---|
| Micro-Plate -- Rabbit anti-morphine antibody immobilized on a polystyrene plate supplied |
| n dry form. |
| Enzyme Conjugate -- Horseradish peroxidase labeled with a morphine hapten diluted in a |
| rotein 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. |
| STC Negative Calibrator -- OraSure® Control Matrix negative for morphine. |
| STC Opiates Negative Control -- OraSure® Control Matrix containing 5 ng/mL |
| (± 3 ng/mL) morphine. |
| STC Opiates Cutoff Calibrator -- OraSure® Control Matrix containing 10 ng/mL (± 3 |
| g/mL) morphine. |
| STC Opiates Positive Control -- OraSure® Control Matrix containing 20 ng/mL (± 3 |
| g/mL) morphine. |
Principle of the OraSure® 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 opiates are present in oral fluid following human use is well documented. (2)
OraSure 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 opiates in the STC Opiates Micro-Plate EIA manufactured by STC Technologies, Bethlehem, PA. Refer to the OraSure® Oral Specimen Collection Device product insert from Epitope for specific instructions on the proper collection, handling, and adequacy of saliva samples
- રું . Intended Use Statement
The STC Opiates Micro-Plate EIA is intended for use in the qualitative determination of opiates in oral fluid collected with the OraSure Specimen Collection Device. For In Vitro Diagnostic Use.
2
- Summary of Technological Characteristics 6.
The STC Opiates Micro-Plate EIA is based on the principle of solid phase competitive enzyme immunoassay . This application is for the modified use of the STC Opiates ELA urine kit for the detection of opiates using specimens collected with the OraSure® Oral Specimen Collection Device manufactured by Epitope, Inc., Beaverton, Oregon. The kit is essentially the same as the predicate urine kit. However, additional standards (supplied with the kit) have been prepared from the OraSure® Specimen Diluent in the OraSure® Collection Device.
807.92 (b):
- Non Clinical Data 1.
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 (Ao) minus the noise times three (LOD = Ao - 3SD). The LOD was determined by obtaining the absorbance value for twelve blank OraSure® devices and calculating the standard deviation (SD) of the absorbance values. The absorbance value minus 3SD was then extrapolated from the curve and represents the sensitivity of the assay. The LOD was calculated to be 0.2 ng/mL.
Precision - The precision of the STC Opiates Micro-Plate EIA was assessed by testing OraSure® Control Matrix containing 0, 5, 10, or 20 ng/mL morphine. 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:
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| | | |
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LARRIERA In REENWORD LEASTER BROMERS IN LE MUNICIPALIES LE MUNICIPALIES LE MUNICIPALIES LE MUNICIPALIES LEA MULTION | SELECT COLLECT CLAIM OF & MILE OF STORE SECT COLLECT COLLEGION | CANTON INSTITUTION |
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 Opiates Micro-Plate EIA is defined as the apparent morphine concentration divided by the spiked concentration times 100.
The cross-reactivity of structurally related compounds was calculated at several spiked concentrations in normal human urine. The following table indicates the apparent concentration of morphine for each substance at a concentration which cross-reacted in the assay.
3
| Compound | Tested Concentration
(ng/mL) | Morphine Equivalents
(ng/mL) | Cross-Reactivity
(%) |
|------------------------------|---------------------------------|---------------------------------|-------------------------|
| 6-Acetylmorphine | 100 | 14.1 | 14 |
| Codeine | 10 | >100 | >100 |
| Dextromethorphan | 10000 | 100 |
| Hydrocodone | 5 | 33 | >100 |
| Hydromorphone | 100 | 79 | 79 |
| Levorphanol | 100 | 24 | 24 |
| Meperidine | 10000 | 10 | 0.1 |
| Morphine | 10 | 10 | 100 |
| Morphine-3-β-
Glucuronide | 100 | 21 | 21 |
| Nalorphine | 1000 | 11 | 1.2 |
| Normorphine | 1000 | 7 | 0.7 |
| Oxycodone | 1000 | 19 | 1.9 |
| Oxymorphone | 10000 | 51 | 0.5 |
The following compounds cross-react in the assay at the levels shown:
*n.d. = not detectable
The following compounds were spiked into OraSure® Control Matrix at a target concentration of 10,000 ng/mL and tested for cross-reactivity. None were found to produce a signal less than or equal to that of the Opiates Cutoff Calibrator.
| Acetylsalicylic Acid | Clorazepate | L-Ephedrine | Pentobarbital |
|---|---|---|---|
| Alprazolam | Cocaethylene | L-Methamphetamine | Phenobarbital |
| Amobarbital | Cocaine | Lidocaine | Phenylephrine |
| Ampicillin | Cotinine | Medazepam | Phenylpropanolamine |
| β-Phenethylamine | D-Amphetamine | Methadone | Procainamide |
| Benzoylecgonine | D-Methamphetamine | Metroprolol | Procaine |
| Butabarbital | Fenoprofen | Naproxen | Pseudoephedrine |
| Butalbital | Gemfibrozil | Niacinamide | Quinidine |
| Caffeine | Gentisic Acid | Norchlordiazepoxide | Temazepam |
| Chlordiazepoxide | Glipizide | Nordiazepam | Δ9-THC |
| Chlorpromazine | Ibuprofen | PCP | Theophylline |
| Clonazepam | Imipramine | Penicillin | Zomepirac |
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
Accuracy
The clinical sensitivity and specificity of the STC Micro-Plate assay were determined by testing specimens from chronic opiate users. A controlled dose study was also conducted to determine a minimum dose to produce a positive response in the STC EIA. Both studies are described below. The cutoffs for EIA and GC/MS were 10 ng/mL and 15 ng/mL, respectively, for OraSure® specimens. For urine specimens, the EIA cutoff was 300 ng/mL and the GC/MS cutoff was 150 ng/mL (based on SAMHSA recommendations).
4
Study 1 - Chronic Opiates Users
Matched urine and OraSure® specimens were collected from ten (10) self-reported opiates users. An additional fifty (50) presumed negative samples were also included in the analysis. All sixty (60) samples were tested in the STC Opiates Micro-Plate EIA and presumed positives (10) were also tested by gas chromatography/mass spectrometry (GC/MS). Results are presented in the following tables:
| | ------------- | VMS*
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*Of the 10 samples presumed positive, the % sensitivity and % specificity of the OraSure® STC EIA as compared to GC/MS were 100.0% and 87.5%, respectively.
Image /page/4/Figure/4 description: This image shows a table comparing Urine-STC EIA (300 ng/mL Cutoff) and OraSure-STC EIA (10 ng/mL Cutoff). The table shows the number of positive and negative results for each test. For Urine-STC EIA, there are 3 positive and 0 negative results, while for OraSure-STC EIA, there are 4 positive and 53 negative results. The relative sensitivity is 42.9% and the relative specificity is 100.0%.
|
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|
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** Of the 10 samples presumed positive, the % sensitivity and % specificity of the urine STC EIA as compared to GC/MS were 87.5% and 100.0% respectively.
It is believed that the poor agreement between the STC Opiates Micro-Plate EIA (OraSure® application) and the STC Opiates Micro-Plate EIA (urine) is driven by differences in the metabolism of heroin and partitioning in oral and urine. Opiates generally appear later in urine and persist for up to 3-6 days. " Conversely, opiates in saliva is not detectable after 2-8 hours. 10 These differences do not diminish the clinical utility of either fluid. However, users should be aware of these differences.
Study 2 - Controlled Dose Study
A total of 5 volunteers in a controlled environment were administered an initial 3 mg of intravenous heroin HCl, followed by a second 6 mg or 12 mg heroin dose 4 to 12 days later. Saliva and urine samples were collected before dosing and periodically for up to 74 hours after dosing. Saliva specimens (400 uL) were added to the collection pad of the OraSure Oral Fluid Collection Device and processed according to the package insert. Samples were then tested using the STC assay and GC/MS.
Using a 10 ng/mL cutoff for OraSure® samples, opiates were detectable by EIA for up to 2 hours after a 12 mg heroin dose and not detectable at any time for a 3 or 6 mg dose. Of the GC/MS saliva results, only the initial post-12 mg dose samples contained drug concentrations above the 15 ng/mL LOD/LOQ. This demonstrates the ability of the STC
5
GC/MS saliva results, only the initial post-12 mg dose samples contained drug concentrations above the 15 ng/mL LOD/LOQ. This demonstrates the ability of the STC EIA to detect opiate concentrations at intravenous doses as low as 12 mg heroin HCl. The ability of the kit to detect opiates at doses between 6 mg-12 mg is unknown.
- Conclusions 3.
A comparison of the performance data for the new device vs. the predicate device is given on the following page:
6
STC OPIATES MICRO-PLATE EIA (ORASURE® DEVICE)
PERFORMANCE DATA COMPARISON
1. Limit of Detection
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2. Precision
| Assay | Intra-Assay % CV
Range for Levels
Tested | Inter-Assay % CV
Range for Levels
Tested |
|----------------------------------------|------------------------------------------------|------------------------------------------------|
| STC Opiates Micro-Plate EIA (Urine) | 5.5 | 6.3 |
| STC Opiates Micro-Plate EIA (OraSure®) | 8-17 | 9-13 |
3. Sample pH Effect
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|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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4. Effect of Common Materials
| Assay | Adulterants Which Affect Assay Results |
|---|---|
| STC Opiates Micro-Plate EIA (Urine) | Not Tested |
| STC Opiates Micro-Plate EIA (OraSure®) | Cranberry Juice |
| Orange Juice | |
| Cola | |
| Cough Syrup |
7
5. Cross-Reactivity
| Compound | Tested Conc.
(ng/mL) | OraSure® Assay | % Cross-Reactivity in the STC Opiates Micro-
Plate EIA
Urine Assay, Positive @ |
|------------------------------|-------------------------|----------------|--------------------------------------------------------------------------------------|
| 6-Acetylmorphine | 100 | 14 | 500 ng/mL |
| Codeine | 10 | >100 | 75 ng/mL |
| Dextromethorphan | 10000 | >0.1 | Not Tested |
| Diacetylmorphine | 5 | >100 | 600 ng/mL |
| Hydrocodone | 5 | >100 | 300 ng/mL |
| Hydromorphone | 100 | 79 | 600 ng/mL |
| Levorphanol | 100 | 24 | 4500 ng/mL |
| Meperidine | 10000 | 0.1 | Not Tested |
| Morphine-3-β-
Glucuronide | 100 | 21 | 125,000 ng/mL |
| Nalorphine | 1000 | 1.2 | 125,000 ng/mL |
| Normorphine | 1000 | 0.71 | 125,000 ng/mL |
| Oxycodone | 1000 | 1.9 | 125,000 ng/mL |
| Oxymorphone | 10000 | 0.51 | 125,000 ng/mL |
Rs. Nudlah
R. Sam Niedbala, Ph.D., BCFE Executive Vice President
8
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 2 1998
R. Sam Niedbala, Ph.D. . Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799
Re : K981341 STC Opiates Micro-Plate EIA Requlatory Class: II Product Code: DJG Dated: April 8, 1998 Received: April 13, 1998
Dear Dr. Niedbala:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate abe Beaced in the eny 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
981341 510(k) Number (if known):
Device Name: STC Opiates Micro-Plate EIA
Indications For Use: The STC Opiates Micro-Plate EIA is intended for use in the qualitative determination of opiates in oral fluid collected with the OraSure® Oral Collection Device. For In Vitro Diagnostic Use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
c:\fda\indica.doc
OR
Over-The-Counter Use - Over
Division Sign-Off)
ivision of Clinical Laboratory Devices
10(k) Number. K941341