MEDTOX OXYCODONE

K060351 · Medtox Diagnostics, Inc. · DJG · May 12, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060351
• Device Name: MEDTOX OXYCODONE
• Applicant: Medtox Diagnostics, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: May 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Indications for Use

The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription use. The test detects oxycodone at concentrations of 100 ng/mL and above. The MEDTOX® OXYCODONE assay 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) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result.

Device Story

The MEDTOX® OXYCODONE is a lateral flow immunochromatographic test strip for qualitative detection of oxycodone in human urine. The device uses a competitive binding principle: mouse monoclonal antibody specific to oxycodone is conjugated to colloidal gold; drug-protein conjugate is immobilized at the test line. In the absence of drug, gold-labeled antibody binds to the test line (visible red line). In the presence of drug at or above 100 ng/mL, the drug binds the gold-labeled antibody, preventing binding to the test line (no line). An internal control line confirms proper sample volume and reagent migration. The device is used in point-of-care, clinical, and forensic settings by trained operators. Results are read visually. The test provides a preliminary analytical result; positive results require confirmation by a more specific method like GC/MS. The device aids in identifying potential drug use, allowing healthcare providers to initiate further diagnostic or clinical evaluation.

Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted with in-house operators and 9 POC operators at 3 sites using spiked urine samples. Results showed 100% agreement for negative samples (0-25 ng/mL) and high agreement for positive samples (125-150 ng/mL). Method comparison study against GC/MS (n=not specified) showed 96% agreement among positives and 97% agreement among negatives. Cross-reactivity and interference studies evaluated various endogenous compounds, prescription, and OTC medications; no significant interference reported.

Technological Characteristics

Lateral flow immunochromatographic assay. Cassette format with plastic housing and dropper. Mouse monoclonal anti-oxycodone test antibody; rabbit polyclonal anti-mouse control antibody. Visual readout; no instrumentation required. Qualitative detection at 100 ng/mL cutoff.

Indications for Use

Indicated for the rapid, qualitative detection of oxycodone in human urine at concentrations of 100 ng/mL and above. Intended for prescription use in point-of-care, physician office laboratories, central laboratories, workplace, criminal justice, forensic, and drug rehabilitation settings. Not for over-the-counter sale.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• DRI Oxycodone Assay, 100 ng/mL Cutoff (K040411)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number
k060351

B. Purpose for Submission:
New device

C. Measurand:
Oxycodone

D. Type of Test:
Qualitative immunoassay, lateral flow immunochromatographic

E. Applicant:
MedTox Diagnostics

F. Proprietary and Established Names:
MedTox Oxycodone

G. Regulatory Information:
1. Regulation section:
21 CFR 862.3650, Enzyme Immunoassay, Opiates
2. Classification:
Class II
3. Product Code:
DJG
4. Panel:
Toxicology (91)

H. Intended Use:
1. Intended use(s):
Refer to Indications for use below.
2. Indication(s) for use:
The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription use.

The test detects oxycodone at concentrations of 100 ng/mL and above.

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The MEDTOX® OXYCODONE assay 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) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result.

3. Special condition for use statement(s):

The MEDTOX® OXYCODONE 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) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result.

The assay is intended for prescription use in point-of-care settings.

Tests for oxycodone cannot distinguish between abused drugs and certain prescribed medications.

Certain foods or medications may interfere with tests for oxycodone and cause false positive results.

4. Special instrument Requirements:

Not applicable. The device is a visually read single-use device.

I. Device Description:

The product is a single-use device in a cassette format. The device includes the immunochromatographic strip enclosed in plastic, a plastic dropper for dispensing urine, and the package insert. At one end is the sample well where the urine sample is applied. The test reaction is initiated by movement of the sample through the test strip. In the middle of the device is a read window with a test line for oxycodone and a control line. Above the read window are interpretations for negative or non-negative for the test line and valid or invalid for the control line.

Description of the test antibody: monoclonal mouse antibody against oxycodone.

Description of the control line antibody: rabbit polyclonal anti-mouse.

J. Substantial Equivalence Information:

1. Predicate device name(s):

DRI Oxycodone Assay

2. Predicate 510(k) number(s):

k040411

3. Comparison with predicate:

Both devices are for the qualitative determination of the same analyte in the same matrix, and utilize the same cutoff concentration. The predicate uses

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liquid reagents on automated clinical chemistry analyzers. The candidate device is visually read and designed for single use only.

The reagent formulations vary between the two devices.

| Similarities | | |
| --- | --- | --- |
| Item | Predicate | Device |
| Cutoff | Same | 100 ng/mL |
| Cross-reactivity to opiates and oxycodone metabolites other than oxymorphone | Less than 1% | 2% or less |
| Test Antibodies | Same | Mouse monoclonal anti-oxycodone |
| Differences | | |
| --- | --- | --- |
| Item | Predicate | Device |
| Methodology | Automated homogeneous enzyme immunoassay | Lateral flow immunochromatographic |
| Procedure | Automated | Manual |
| Controls | Controls must be run separately in the same manner as patient samples | Control provided on each strip |
| Calibration Required | Yes | No |
| Cross-reactivity to oxymorphone (primary metabolite) | 103% | 50% |

K. Standard/Guidance Document Referenced (if applicable):
The sponsor did not reference any standards in this submission.

L. Test Principle:
The test employs lateral flow immunochromatographic technology.

Drug in the sample and drug-labeled conjugate (containing a chromagen) compete for antibody binding sites in the test area of the test strip. Binding of drug in the sample causes the absence of a line at the test area, i.e., a positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. The absence or presence of the line is determined visually by the operator.

The device also has an internal process control which indicates that an adequate volume of sample has been added and that the immunochromatographic strip is intact.

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# M. Performance Characteristics (if/when applicable):

## 1. Analytical performance:

a. Precision/Reproducibility:

The sponsor performed two Precision/Reproducibility studies. The first was conducted at the sponsor's facility.

Specimen description: drug free urine spiked with oxycodone
Number of days: three
Replicates per day: two
Lots of product used: one
Number of operators: three
Operator: manufacturer staff
Testing Facility: manufacturer

Results of the study are presented below:

Oxycodone Precision Study Results at Sponsor's Facility

| Concentration of sample, ng/mL | Number of determinations | Results # Neg/ #Pos |
| --- | --- | --- |
| 0 | 54 | 54/0 |
| 25 | 54 | 54/0 |
| 50 | 54 | 50/4 |
| 75 | 54 | 14/40 |
| 100 | 54 | 4/50 |
| 125 | 54 | 1/53 |
| 150 | 54 | 0/54 |

The second precision study was performed at three point of care sites.

Specimen description: drug free urine spiked with oxycodone
Number of days: one
Replicates per day: ninety (six concentrations X fifteen replicates per concentration)
Lots of product used: one
Number of operators: nine
Operators: POC staff, DOA Collection Center Staff, Rehabilitation Center Staff
Testing Facilities: Three POC sites

Results of the study are presented below:

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Oxycodone Precision Study Results at Point of Care Sites

| Concentration of sample, ng/mL | Number of determinations | | | Results # Neg/ #Pos | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Site 1 | Site 2 | Site 3 | Site 1 | Site 2 | Site 3 |
| 0 | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 |
| 25 | 15 | 15 | 15 | 15/0 | 15/0 | 15/0 |
| 50 | 15 | 15 | 15 | 13/2 | 15/0 | 14/1 |
| 100 | 15 | 15 | 15 | 0/15 | 3/12 | 3/12 |
| 125 | 15 | 15 | 15 | 0/15 | 2/13 | 1/14 |
| 150 | 15 | 15 | 15 | 0/15 | 0/15 | 0/15 |

b. Linearity/assay reportable range:
Not applicable. The assay is intended for qualitative use.

c. Traceability (controls, calibrators, or method):
External control materials are recommended but are not specifically identified in the labeling.

The device has an internal process control. Users are instructed to follow federal, state, and local guidelines when determining when to run external controls.

d. Detection limit:
Sensitivity of this assay is characterized by validating performance around the claimed cutoff concentration (100 ng/mL) of the assay, including a determination of the lowest concentration of drug that is capable of producing a positive result.

This information appears in the precision section, above.

e. Analytical specificity:
Cross-reactivity was established by spiking various concentrations of similarly structured drug compounds into drug-free urine. By analyzing various concentration of each compound the sponsor determined the concentration of the drug that produced a response approximately equivalent to the cutoff concentration of the assay. Results of those studies appear in the table(s) below:

| Drug compound | Response equivalent to cutoff in ng/mL | Percent Cross-Reactivity |
| --- | --- | --- |
| 6-monoacetylmorphine | Negative at 100,000 | < 1% |
| Apomorphine | Negative at 100,000 | < 1% |

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| Drug compound | Response equivalent to cutoff in ng/mL | Percent Cross-Reactivity |
| --- | --- | --- |
| Codeine | 5,000 | 2% |
| Dihydrocodeine | 10,000 | 1% |
| Ethylmorphine | 5,000 | 2% |
| Heroin | Negative at 100,000 | < 1% |
| Hydrocodone | 75,000 | < 1% |
| Hydromorphone | 50,000 | < 1% |
| Levorphanol | Negative at 50,000 | < 1% |
| Morphine | 50,000 | < 1% |
| Morphine-3-β-glucuronide | Negative at 100,000 | < 1% |
| Morphine-6-β-glucuronide | Negative at 100,000 | < 1% |
| Nalorphine | Negative at 100,000 | < 1% |
| Drug compound | Response equivalent to cutoff in ng/mL | Percent Cross-Reactivity |
| --- | --- | --- |
| Naloxone | 50,000 | < 1% |
| Naltrexone | Negative at 100,000 | < 1% |
| Norcodeine | 100,000 | < 1% |
| Oxymorphone | 200 | 50% |
| Thebaine | Negative at 100,000 | < 1% |

The following compounds were evaluated for potential positive and/or negative interference with the assay. To evaluate for interference the sponsor prepared two control samples that consisted of drug-free urine spiked with 25 ng/mL (to test for positive interference) and 150 ng/mL (to test for negative interference) of oxycodone. Next, 100 µg/mL of all of the potentially interfering compounds were added to separate aliquots of the control samples and analyzed. There were no deviations from the expected results for the following compounds:

Acetylsalicylic Acid
Acetaminophen
Brompheniramine
Caffeine
Carbamazepine
Chlorpheniramine
Cocaine
Doxylamine
Dextromethorphan
5,5 Diphenylhydantoin
Ibuprofen
Phenobarbital
d-Pseudoephedrine
Salicylic Acid

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The sponsor did a second interference study which tested for positive interference only. It is noted that these compounds were spiked into drug-free urine (zero concentration oxycodone) only. All of the compounds listed below were spiked in at a concentration of 100 µg/mL with the following exceptions:

Alprazolam @ 25 µg/mL, Alprazolam, 1-Hydroxy @ 10 µg/mL, Buprenorphine @ 10 µg/mL, Fentanyl @ 10 µg/mL, 11-hydroxy-Δ⁹-THC @ 10 µg/mL, Lorazepam glucuronide @ 10 µg/mL, 11-Nor-9-carboxy Δ⁹-THC @10 µg/mL, Olanzapine @ 10 µg/mL, Oxazepam glucuronide @ 10 µg/mL, and Triazolam, 1-hydroxy @ 10 µg/mL. There were no deviations from the expected negative results.

| Acecainide | Caffeine | Dextromethorphan |
| --- | --- | --- |
| Acetaminophen | Cannabidiol | Diazepam |
| Acetylsalicylic Acid | Cannabinol | Diclofenac |
| Allobarbital | Captopril | Diethylpropion |
| Alprazolam | Carbamazepine | Diflunisal |
| Alprazolam, 1-Hydroxy p-Aminobenzoic Acid | Carbamazepine, 11 epoxide | Digoxin |
| 7-Amino-clonazepam | Carisoprodol | Dimenhydrinate |
| 7-Amino-flunitrazepam | Cephalexin | 1,3-Dimethylbarbituric acid |
| Aminoglutethimide | Chloral Hydrate | Diphenhydramine |
| l-Aminopyrine | Chloramphenicol | e |
| Amitriptyline | Chlordiazepoxide | Domperidone |
| Amobarbital | Chloroquine | Dopamine |
| Amoxapine | Chlorothiazide | Doxepin |
| Amoxicillin d-Amphetamine | Chlorpheniramine | Doxylamine |
| l-Amphetamine | Chlorpromazine | Ecgonine |
| Ampicillin | Chlorprothixene | Doxyamine |
| Aprobarbital | Clobazam | Ecgonine Methyl Ester |
| l-Ascorbic Acid | Clomipramine | EDDP |
| Aspartame | Clonazepam | Efavirenz |
| Atenolol | Clonidine | EMDP |
| Atropine Sulfate | Clorazepate | Ephedrine |
| Barbital | Clozapine | Equilin |
| Barbituric Acid | Cocaine | Erythromycin |
| Benzic Acid | Cortisone | Estrone |
| Benzocaine | Cotinine | Ethanol |
| Benzoylecgonine | Cyclopentobarbitol | Fenfluramine |
| Benzphetamine | Deoxycorticosterone | Fenoprofen |
| Benztropine | Desalkylflurazepam | Fentanyl |
| Brompheniramine | Desipramine | Flunitrazepam |
| Buprenorphine | Norchlordiazepoxide | Fluoxetine |
| Bupropion | Desmethylflunitrazepam | Lurazepam |
| Butabarbital | Desmethylvenlafaxine | Furosemide |
| Butalbital | Dexamethasone | Fuvoxamine |
| | | Gentisic Acid |
| | | Glutethimide |
| | | Guaiacol Glyceryl Ether |

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| Haloperidol | I- | Perphenazine |
| --- | --- | --- |
| Hexobarbital | Methamphetamine | Phenallymal |
| Hippuric acid | e | Phenacetin |
| Hydralazine | Methaqualone | Phencyclidine |
| Hydrochlorothiazide | Methcathinone | Phendimetrazine |
| Hydrocortisone | Methocarbamol | Phenelzine |
| Hydroxybupropion | Methoxyphenamine | Phenethylamine |
| Hydroxyhippuric acid | Methylphenidate | Pheniramine |
| 1-11-Hydroxy-Δ⁹-THC | Methylprylon | Phenmetrazine |
| p-Hydroxyphenobarbital | Metoprolol | Phenobarbital |
| 4-Hydroxyphencyclidine | Midazolam | Phenothiazine |
| 3-Hydroxytyramine | Mirtazapine | Phentermine |
| Hydroxyzine | Nalidixic Acid | Phentoin |
| Ibuprofen | Naproxen | Phenylbutazone |
| Imipramine | Niacinamide | Phenylephrine |
| Iproniazid | Nicotine | Phenylpropanolamine |
| (R)-Isoproterenol | Nifedipine | Piroxicam |
| Isoxsuprine | Nitrazepam | Prazosin |
| Ketamine | Nitrofurantoin | Prednisolone |
| Ketoprofen | Norclomipramine | Prednisone |
| Labetalol | Nordiazepam | Procaine |
| Lidocaine | Nordoxepin | Procainamide |
| Lithium carbonate | Norethindrone | Prochlorperazine |
| Loperamide | Norlysergic Acid | Promazine |
| Lorazepam | Normeperidine | Promethazine |
| Lorazepam glucuronide | Norpropoxyphene | Propoxyphene |
| Loxapine | I- | Propranolol |
| Lysergic Acid | Norpseudoephedrine | Protriptyline |
| Lysergic Acid | 11-Nor-9-carboxy-Δ⁹-THC | d-Pseudoephedrine |
| Diethylamide | 11-Nor-9-carboxy-Δ⁸-THC | Pyrilamine |
| Maprotiline | Nortriptyline | Quetiapine |
| MDA | Noscapine | Quinidine |
| MDEA | Nylidrin | Ranitidine |
| MDMA | Octopamine | Riboflavin |
| Melanin | Ofloxacin | Rifampin |
| Meperidine | Olanzapine | Salicylic Acid |
| Mephobarbital | Omeprazole | Secobarbital |
| Mepivacaine | Orphenadrine | Selegiline |
| Mesoridazine | Oxalic Acid | Serotonin |
| Methadone | Oxaprosin | Sertraline |
| d-Methamphetamine | Oxazepam | Sildenafil |
| d-Methamphetamine | glucuronide | Sulfamethazine |
| d-Methamphetamine | Oxolinic Acid | Sulindac |
| d-Methamphetamine | Oxymetazoline | Talbutal |
| d-Methamphetamine | Papaverine | Temazepam |
| d-Methamphetamine | hydrochloride | Tetracycline |
| d-Methamphetamine | Penicillin G | Δ⁹-Tetrahydrocannabinol |
| d-Methamphetamine | Pentazocine | Tetrahydrocannabinol |
| d-Methamphetamine | Pentobarbital | Tetrahydrozoline |
| d-Methamphetamine | Thiophyline | Thiamine |
| d-Methamphetamine | Thiamine | Thiopental |

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Thioridazine
Thiothixine
Tolbutamide
Tolmetin
Trazodone
Triamterene
Triazolam
Triazolam, 1-
hydroxy
Trifluoperazine
Trimethoprim
Trimipramine
Tripelennamine
Tryptamine
Tryptophan
Tyramine
Tyrosine
Valproic Acid
Venlafaxine
Verapamil
Zomepirac

There is the possibility that other substances and/or factors not listed above may interfere with the test and cause false results, e.g., technical or procedural errors.

To test for potential positive/and or negative interference from endogenous conditions the sponsor performed the following studies:

To assess the effects of pH on the assay, the sponsor prepared samples from a pH of 4-9 and then to separate aliquots spiked in oxycodone at concentrations of 25 and 150 ng/mL. There were no deviations from the expected results.

The sponsor did a similar study with specific gravity values of 1.003, 1.005, 1.010, 1.015, 1.020, 1.025, 1.030, and 1.035 with urine samples spiked at 25 and 150 ng/mL. There were no deviations from the expected results.

For other endogenous substances, the sponsor performed a study which tested for positive interference only. It is noted that these compounds were spiked into drug-free urine (zero concentration oxycodone) only. The following table lists the compounds, the concentration that was spiked into drug-free urine, and the result.

| Compound | Concentration | MEDTOX Oxycodone result |
| --- | --- | --- |
| Acetaldehyde | 100 μg/ml | NEG |
| Acetone | 100 μg/ml | NEG |
| Albumin, human | 20 mg/ml | NEG |
| Bilirubin | 200 μg/ml | NEG |
| Cholesterol | 100 μg/ml | NEG |
| Creatinine | 100 μg/ml | NEG |
| d,l-Thyroxin | 100 μg/ml | NEG |
| Epinephrine | 100 μg/ml | NEG |
| B-Estradiol | 100 μg/ml | NEG |
| Estriol | 100 μg/ml | NEG |
| Glucose, Standard Solution | 100 μg/ml | NEG |
| Hemoglobin, human | 100 μg/ml | NEG |
| Sodium Chloride | 100 μg/ml | NEG |

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| Compound | Concentration | MEDTOX Oxycodone result |
| --- | --- | --- |
| Tetra hydrocortisone | 100 μg/ml | NEG |
| Uric Acid | 100 μg/ml | NEG |

f. Assay cut-off:
The Substance Abuse and Mental Health Services Administration (SAMHSA) has not recommended a cutoff concentration for oxycodone. The sponsor’s claimed cutoff is 100 ng/mL.

Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, above.

2. Comparison studies:

a. Method comparison with predicate device:
The candidate device was compared both to a reference method, GC/MS, and to the predicate device.

A total of 161 samples (116 negative and 45 positive) were evaluated by the candidate device and by GC/MS and/or the predicate device.

Sample description: Unaltered clinical urine samples were evaluated. 37 additional diluted samples were also included in the study. The samples were prepared by diluting clinical samples with high drug concentrations with drug-free urine. This was done in order to obtain samples near the cutoff concentration of the assay, because the sponsor was not able to obtain unaltered samples near the cutoff.

Sample selection: Samples previously analyzed by the predicate device were selected to be analyzed by the candidate device. Samples were chosen for the study based on whether they screened positive or negative by the predicate device.

Only those samples found positive by the predicate device were analyzed by GC/MS. A portion of samples having drug concentrations that were below the cutoff concentration of the assay were also evaluated by GC/MS.

The study included an adequate number of samples that contained drugs near to the cutoff concentration of the assay. Approximately 10% of the study samples are evenly distributed between plus and minus 50% of the claimed cutoff concentration

Number of study sites: three
Type of study site(s): POC setting

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Operator description: POC staff, DOA Collection Center Staff, Rehabilitation Center Staff

Candidate Device Results vs. stratified GC/MS Values

| Candidate Device Results | Negative by Immunoassay Predicate Device | Concentration of up to the cutoff -50% | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) |
| --- | --- | --- | --- | --- | --- |
| Positive | 0 | 2 | 2 | 6 | 37 |
| Negative | 103 | 5 | 4 | 1 | 1 |

GC/MS values used to categorize samples in this table are determined by adding together the concentration of oxycodone plus 50% of the concentration of oxymorphone, based on the sponsor’s cross-reactivity studies.

% Agreement among positives is 96%
% Agreement among negatives is 97%

The sponsor also performed a method comparison study at their own facility using many of the same samples as in the POC study above. Results between the two studies were similar.

b. Matrix comparison:
Not applicable. The assay is intended for only one sample matrix.

3. Clinical studies:
a. Clinical sensitivity:
Not applicable. Clinical studies are not typically submitted for this device type.
b. Clinical specificity:
Not applicable. Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

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N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.