The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

The Detectabuse® controls are designed to provide an estimation of the precision of a device test system, and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects, at levels established by SAMHSA, CAP/AACC, many state programs and device manufacturers QC requirements. The Detectabuse® control urines are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents. They should be treated as any "unknown" specimen while following the specific protocol of the assay being used. This product is intended to be used under the supervision of health care professionals as an integral part of good laboratory practices.

Device Description

Each bottle contains stabilized human based urine. Multi-constituent and single constituent positive control urines have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain less than 1% sodium azide as a preservative. For assays sensitive to sodium azide such as ELISA we substitute a proprietary preservative approved by the manufacturers and DEA.

AI/ML Overview

This document describes the performance characteristics and acceptance criteria for the Detectabuse® Liquid Control Urine device. This device is an In Vitro Diagnostic (IVD) intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures.

The study that proves the device meets the acceptance criteria is primarily an analytical performance study focusing on stability and traceability.

1. Table of Acceptance Criteria and Reported Device Performance

| Evaluation Parameter | Acceptance Criteria | Reported Device Performance |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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| Open Bottle Stability at 2-8°C | 31 days | Data support the 31-day open bottle stability at 2-8°C for all analytes. All analytes passed specifications, Positive controls tested positive, and Negative controls tested negative. |
| Closed Bottle Stability - Product Shelf Life (2-8°C) | Storage with Oxazepam expected to be negatively affected if >6 months. Other drugs within ±15% of target until expiration. | At 1 year, Oxazepam dropped 15-22%. At 3 years, Oxazepam dropped to 25%. Other drugs were within acceptable criteria of +/-15% from target until expiration date. Recommendation: Do not store Oxazepam-containing controls refrigerated for more than six months. |
| Closed Bottle Stability - Product Shelf Life (-10°C to -20°C) | Up to 4 years. Values within ±15% of target or original test value. | Multiple studies with various lots showed all drugs were stable within 15% of target or original test value between 3 and 4 years of frozen storage. |
| Room Temperature (open vial) Stability - Product Shelf Life (18°C to 21°C) | 31 days. Values within ±18% of target or original test value. | All drugs tested for 31 days were within 18% of target value or original test value. This supports stability during shipping or brief periods of customer error. |
| Value Assignment Criteria | Initially: ±5% agreement (acceptable to ±10% for certain difficult-to-test drugs). For Stat-Skreen® controls, positive controls must test positive and negative controls test negative. Final testing at shelf life: ±10% of target (acceptable to ±15% for certain stability-prone constituents like Oxazepam). | Initial production batch samples sent to 4-5 certified laboratories (at least 3 proficient for specific constituents). If a testing laboratory does not report within 10% of target, the sample is repeated. Once acceptable convergence of values is achieved, the lot is released. Stat-Skreen® controls are also tested on handheld devices against the criteria. Final testing at shelf life (GC/MS or LC/MS) aims for ±10% of target but accepts up to ±15% for specific constituents like Oxazepam. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for "test sets" in the context of typical algorithm validation (i.e., a distinct set used for performance evaluation after training). Instead, the performance evaluations are described for stability studies and value assignment verification.

Stability Studies: "Multiple bottles of a single lot" were pulled from beginning, middle, and end of production. "Several lots" of controls were selected for the room temperature study. "Multiple studies were conducted using various different lots."
Value Assignment: "An initial production batch is sampled as described in the protocol and single or multiple samples (depending on our past experience with the constituent(s), are ordinarily sent out to 4 or 5 certified laboratories..."
Data Provenance: The data is generated through laboratory testing of the control materials. The document implies a prospective data collection for stability studies (testing at initial, then at intervals) and for value assignment. The "certified independent laboratories" or "SAMHSA licensed laboratories or CAP inspected and certified" are likely located in the USA, given the FDA submission context.

3. Number of Experts and Qualifications for Ground Truth

Ground Truth Establishment for Value Assignment: "Certified Independent laboratories" test by either GC/MS, LC/MS, or Immunoassay screening. For initial value assignment, "4 or 5 certified laboratories" (or at least 3 for less common constituents) perform testing. The qualifications for personnel performing these tests at "certified" or "SAMHSA licensed" or "CAP inspected and certified" labs are implied to be high, but specific expert qualifications (e.g., "radiologist with 10 years of experience") are not detailed. The expertise is in the analytical methods (GC/MS, LC/MS, immunoassay).

4. Adjudication Method

The adjudication method for value assignment resembles a form of consensus or agreement-based approach.

"A minimum of 3 data points are collected for each assay."
"Data collected from at least two test sites, testing performed within 1 week of receipt of test samples."
"Our target acceptance criteria Is ±5% of the target value, but if we cannot get ± 5% agreement from our testing laboratories we will accept ± 10%... If a testing laboratory does not report within 10% of target we ask that the sample be repeated. Once we have an acceptable convergence of values from all of the testing laboratories the lot is released."

This suggests repeated testing and comparison among multiple labs with defined acceptance thresholds for agreement, rather than a formal 2+1 or 3+1 adjudication by individual experts in the traditional sense for image interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a quality control material, not an AI diagnostic tool intended to assist human readers. Therefore, the concept of improving human reader performance with AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was done in the sense that the device, as a quality control material, is evaluated on its own analytical properties (stability, assigned values, precision monitoring capability) using laboratory instruments. There isn't an "algorithm" in the typical AI sense; the "device" itself is the control material. Its performance is measured by how precisely and accurately analytical instruments can detect the specified concentrations within the control.

7. Type of Ground Truth Used

The ground truth used for this device is based on analytical quantification methods and certified reference standards:

Gravimetric spiking with authentic reference drug standards and/or appropriate metabolites.
Purity determination using analytical tools including GC/MS, LC/MS, and NMR.
Balances calibrated with weights traceable to National Institute of Standards and Technology (NIST).
Testing by SAMHSA or CAP certified independent laboratories using GC/MS, LC/MS, or Immunoassay screening.
Negative control urines are certified negative by combination of immunoassay, GC/MS and/or LC/MS.

This constitutes a highly rigorous, metrologically traceable analytical ground truth.

8. Sample Size for the Training Set

The concept of a "training set" as understood in machine learning is not applicable here. This device is a chemical control material, not an AI algorithm that learns from data. The manufacturing and validation processes involve:

Reference standards and gravimetric preparation: These form the basis for the intended concentrations.
Initial production batches: These are the manufacturing lots that undergo value assignment and stability testing as described above.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no "training set" in the AI sense. The "ground truth" (i.e., the known and verified concentrations of analytes in the control material) is established through:

Precise gravimetric preparation: Spiking authentic reference drug standards (traceable to NIST) into the human-based urine matrix at known concentrations.
Purity verification of reference standards: Using advanced analytical techniques such as GC/MS, LC/MS, and NMR.
Verification by multiple independent certified laboratories: The value assignment process, involving multiple labs and stringent acceptance criteria, serves to confirm the prepared concentrations with high confidence.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 23, 2016

BIOCHEMICAL DIAGNOSTICS, INC ALLEN PANETZ PRESIDENT 180 HEARTLAND BLVD EDGEWOOD NY 11717

Re: K153474

Trade/Device Name: Detectabuse® Stat-Skreen Liquid Control Urine. Detectabuse® Liquid Control Urine, AU/NZ Detectabuse® Liquid Control Urine, Immunoassay Series Detectabuse® Liquid Control Urine, Confirm Series Detectabuse® Liquid Control Urine, GC/MS Detectabuse® Liquid Control Urine Series, Single or Multi-Constituent Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: I, reserved Product Code: DIF Dated: December 3, 2015 Received: December 4, 2015

Dear Allen Panetz:

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. 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 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

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CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153474

Device Name

Detectabuse® Stat-Skreen Liquid Control Urine, Detectabuse® Liquid Control Urine, AU/NZ, Detectabuse® Liquid Control Urine, Immunoassay Series, Detectabuse® Liquid Control Urine, Confirm Series, Detectabuse® Liquid Control Urine, GC/MS, Detectabuse® Liquid Control Urine Series, Single or Multi-Constituent

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows a black square with rounded corners. Inside the square is a white drawing of a tool, possibly a pipette or similar laboratory instrument. The tool has a cylindrical body that tapers to a narrow tip at the bottom, and it has several sections that appear to be connected or stacked on top of each other.

Biochemical Diagnostics, Inc. 180 Heartland Blvd, Edgewood, NY 11717 · Phone (800) 223-4835 Fax (631) 595-9204 · www.biochemicaldiagnostics.com

An ISO 13485:2003 Company

Traditional 510(k) Submission

Number: K15347

A. 510(k) Number: K153474

Date of Summary Preparation

January 15, 2016

B. Purpose for Submission: New Device

C. Measurand:

Quality control material for urine testing of:

Delta-9-THC-COOH, Benzoylecgonine, Phencyclidine(PCP), Morphine, Morphine -3-glucuronide, 6-Monoacetylmorphine(6-MAM). Codeine, Oxycodone, Buprenorphine, Fentanyl, d-Amphetamine, d-Methamphetamine, 3, 4-Methylenedioxymethamphetamine (MDMA), 3, 4-Methylenediox yamphetamine (MDA). 3, 4-Methylenediox y-N-ethylamphetamine (MDEA), Secobarbital, Phenobarbital, Butalbital, Oxazepam, Nordiazepam, Methadone, EDDP, Methaqualone, Propoxyphene, Norprox yphene, Nortriptyline, Cotinine, Ethanol, Amphetamines, Cannabinoids, Opiates, Barbiturates, Benzodiazepines, Hydrocodone, , Buprenorphine Glucuronide, Lysergic Acid, , Acetaminophen, Tramadol, Creatinine, pH, Specific Gravity.

D. Type of Test:

Not applicable

E. Applicant:

Biochemical Diagnostics, Inc. 180 Heartland Blvd Edgewood, NY 11717 Phone: 631-595-9200 Fax: 631-595-9204

Contact Person

Allen Panetz President Phone: 631-595-9200 Ext. 3011

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F. Proprietary and Established Names:

Product trade name: Detectabuse® Liquid Control Urine

Established Names Include: Detectabuse® Stat-Skreen® Liquid Control Urine Detectabuse® Liquid Control Urine, AU/NZ Detectabuse® Liquid Control Urine, Immunoassay Series Detectabuse® Liquid Control Urine, Confirm Series Detectabuse® Liquid Control Urine, GC/MS Detectabuse® Liquid Control Urine Series, Single or Multi-Constituent

G. Regulatory Information:

Product Code	Classification	Regulation Section	Panel
DIF	Class I, reserved	21 CFR 862.3280	Toxicology

H. Intended Use:

1. Intended use(s):
  The Detectabuse® Liquid control is an In Vitro Diagnostic (IVD) device, for prescription use only, that is intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert.

2. Indication(s) for use:

1. Special conditions for use statement(s):
  Detectabuse® Liquid Control Urines are designed for in vitro diagnostic use only and are available in Negative, and concentrations ranging between Cutoff -80%, and 4X Cutoff levels. They should not be pipetted by mouth and the normal precautions for handling laboratory specimens should be applied. The products contain either sodium azide or a proprietary preservative compatible with products that are adversely affected by sodium azide.

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4. Special instrument requirements:

Validation studies were conducted using the following methods:

1. GC/MS
LC/MS 2)
Immunoassay Screening (immunoassay analyzer, Roche Cobas 6000 analyzer 3) and/or immunoassay single use screening devices)

I. Device Description:

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J. Substantial Equivalence Information:

1. Predicate device (K121122)

Detectabuse® Liquid Control Urine

2. Comparison of Technological Characteristics

Similarities and differences between new and predicate devices. Drug screening tests are for use with FDA approved test methods.

Device	Predicate Device A (K121122)	Device (K153474)
Characteristics	Detectabuse® Liquid Control Urine	Detectabuse® Liquid ControlUrine includes:Stat-Skreen®, AU/NZ SkreenImmunoassay SeriesGC/MS, Confirm Series,Single or Multi-ConstituentSeries
Intended Use	The Detectabuse®Liquid control is an In VitroDiagnostic (IVD) device, for prescription use only,that is intended for use as quality control urine tomonitor the precision of laboratory urine toxicologytesting procedures for the analytes listed in thepackage insert.	SAME
Target DrugLevels (Seepackage insertsfor ng/mL targetvalues)	GC/MS: cutoff, cutoff -25%, cutoff +25%cutoff	Concentration ranges:
		Stat-Skreen Negative and cutoff
	Immunoassay: cutoff, cutoff -25%, cutoff	-80% to 4X cutoff
	+25%, 3X	Immunoassay: Negative and cutoff-80% to 4X cutoff
		GC/MS and AU/NZ Skreen:
		Negative and cutoff -80% to 4Xcutoff
		Confirm series:Negative and cutoff -80% to 4XcutoffSingle or Multi-ConstituentSeries:Negative and cutoff -80% to 4Xcutoff

Device	Predicate Device A (K121122)	Device (K153474)
Form	Liquid	Liquid
Matrix	Human Urine	Human Urine
Storage	A. The controls are stable until the expirationdate when stored at -10 to -20°C andprotected from light.B. The controls are stable until the expirationdate when stored at 2-8°C.	UnopenedA. The controls are stable until theexpiration date when stored at -10to -20°C and protected from light.B. The controls are stable until theexpiration date when stored at 2-8°C.
Analytes	Delta-9-THC-COOH, Benzoylecgonine ,Phencyclidine (PCP), Codeine, Propoxy pheneMethaqualone, Morphine -3-glucuronide,6-Monoacetylmorphine, Morphine,d-Amphetamine, d-Methamphetamine,Secobarbital, Butalbital, Phenobarbital,Oxazepam, Methadone, MDMA, MDA,MDEA, Oxycodone, Buprenorphine, EDDP,Nordiazepam, Norpropoxyphene, Cotinine,Fentanyl, Ethanol, Nortriptyline, Creatinine,pH, Specific Gravity	Same analytes as predicate deviceA with the additional claims:Detectabuse® Liquid ControlUrine includes:Stat-Skreen®, AU/NZ SkreenImmunoassay Series, GC/MS,Confirm Series, Single or Multi-Constituent Series:Cannabinoids, Opiates,Amphetamines, Benzodiazepines,Barbiturates, Hydrocodone, ,Buprenorphine Glucuronide,Lysergic Acid, Acetaminophen,Tramadol

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K. Standard/Guidance Document Referenced (if applicable):

None were referenced.

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
- a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

The drug values in the Detectabuse® control are validated by SAMHSA or CAP certified independent laboratories by using either GC/MS, LC/MS, HPLC, or Immunoassay screening. The controls are manufactured using reference standards supplied by companies including Cerilliant and Alltech Corporation. Accuracy is certified by purity determination using analytical tools including GC/MS, LC/MS, and NMR. Gravimetric preparation is accomplished using balances calibrated with weights that are traceable to National Institute of Standards and Technology (NIST).

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Metrological Traceability of Values Assigned to Control Materials

Detectabuse® Liquid Control Urines have target value assignments for various drug constituents. Laboratories (or other end-users) are to use these target concentrations when performing screening or confirmation of drugs of abuse testing methods.

Image /page/9/Figure/2 description: The image shows a flow chart of the metrological traceability of drug testing. The flow chart starts with a >98% purity drug standard either solutions or powder. The next step is volumetric and gravimetric measurement by balance and pipette (cross-checked). The flow chart ends with the final result (ng/mL).

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Value Assignment:

The following procedure was used for value assignment

a. Assay Methodology used to assign values:

Certified Independent laboratories test by either GC/MS, LC/MS, or Immunoassay screening depending on validated test method that is in use at time of testing.

b. Data Collection:

A minimum of 3 data points are collected for each assay. Data collected from at least two test sites, testing performed within 1 week of receipt of test samples.

c. Value assignment Criteria:

An initial production batch is sampled as described in the protocol and single or multiple samples (depending on our past experience with the constituent(s), are ordinarily sent out to 4 or 5 certified laboratories, depending on the constituents being tested. Certain drug constituents are not routinely tested by all of our reference laboratories and, in this case, we identify at least 3 laboratories that are proficient in those constituents. Our target acceptance criteria Is ±5% of the target value, but if we cannot get ± 5% agreement from our testing laboratories we will accept ± 10%, particularly in the case of certain drugs that are not routinely tested for such as Propoxyphene and Methaqualone. If a testing laboratory does not report within 10% of target we ask that the sample be repeated. Once we have an acceptable convergence of values from all of the testing laboratories the lot is released. In the case of Stat-Skreen® controls for on-site hand held devices, when available, the lot will also be tested on hand held devices listed for the constituents. In this case our criteria shall be that positive controls test positive and negative product tests negative on the device.

For our final testing of a lot by GC/MS or LC/MS at the end of its shelf life we aim for ± 10% of target value but will accept up to ±15% for certain constituents such as Oxazepam that are known to have stability issues.

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Stability Protocol K153474

Biochemical Diagnostics performed stability testing on our Detectabuse® controls to verify the performance claims in our package inserts. Controls were tested at Room Temperature (18-21°C), Refrigerated (2-8°C). Frozen (-10 to -20°C). The protocol and conclusion are listed below.

Open Vial (2-8°C) Stability

Protocol:

Refrigerated temperature on opened vial Detectabuse® controls was tested initially and again at 31 days. Controls run by Drugs of Abuse testing using FDA approved test methods.

Conclusion:

Data support the 31-day open bottle stability at 2-8℃ for all analytes in the lots evaluated. All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative.

Closed Vial (2-8°C) Stability

Protocol:

Refrigerated temperature on closed vial Detectabuse® controls were tested initially and repeated at 1 year and 3 years. Controls run by Drugs of Abuse testing using FDA approved test methods. At expiration date (3 years from manufacture), all drugs tested were stable within 12% of target or original test value done at time of manufacturing with the exception of Oxazepam which dropped 15-22% after one year refrigerated. At study conclusion of 3 years, all drugs were within 15% except Oxazepam which dropped to 25%.

Conclusion:

Refrigerated temperature storage is recommended until expiration date except for Oxazepam which showed a 15-22% drop when stored refrigerated unopened greater than 1 year. Results of other drugs found in our stock Detectabuse product line were within the acceptable criteria of +/-15% from target until expiration date. We do not recommend long term storage (more than six months) refrigerated based on the results of the Oxazepam testing this information is listed on the package insert under unopened Storage & Stability information and under Limitations.

Limitations listed on package insert:

DETECTABUSE CONTROLS, OXAZEPAM STABILITY: Oxazepam has known stability problems in urine stored refrigerated, our studies indicates that Oxazepam will deteriorate when stored refrigerated for longer than 6 months.

Closed Vial (-10°C to -20°C) Stability

Protocol: Multiple bottles of a single lot of individual or multi-constituent Detectabuse® controls were pulled from beginning, middle, and end of production , set aside and unopened bottles were assayed at time of manufacturing and again (unopened bottles) periodically. Studies are ongoing and sent for assay until expiration date. Studies carried out on product between 3 to 4 years frozen storage. Closed vial study samples were stored frozen within a temperature range of -10°C to -20°C. Study samples were tested by GC/MS or LC/MS using SAMHSA licensed laboratories or CAP inspected and certified as well as by our own in-house evaluations using GC/MS and/or FDA approved hand held devices.

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Conclusion:

Multiple studies were conducted using various different lots, tested initially and repeated between 3 and 4 years. Drug levels were quantitated by GC/MS or LC/MS and, all drugs tested were stable within 15% of target or original test value done at time of manufacturing, this information was used to support the limitations listed in our package insert.

Room Temperature (18-21℃)

Protocol:

Several lots of Detectabuse Controls were selected and stored room temperature for up to 31 days. The controls are not recommended to be stored at room temperature, but room temperature storage can occur during delays in shipping or by customer error. This data is used to support stability claims for the constituents of Detectabuse controls. Study samples were tested by GC/MS or LC/MS using SAMHSA licensed laboratories or CAP inspected and certified as well as by our own in-house evaluations using GC/MS and/or FDA approved hand held devices.

Conclusion:

All drugs tested for 31 days by GC/MS or LC/MS and/or FDA approved hand held devices tested within 18% of target value or original test value done at time of manufacture.

Evaluation Parameter	AcceptanceCriteria	Specification	Pass / Fail
Open Bottle Stability at 2-8°C	31 days	Real time study done for31 days	Pass
Close Bottle Stability -	36 months	Storage of	Pass with
Product Shelf Life (2-8°C)		Oxazepam will benegatively affected,>6 months	exception
Close Bottle Stability -Product Shelf Life-10°C to -20°C	Up to 4 years	Real time study, severallots tested. Values within+15%	Pass
Room Temperature (open vial)	31 days	Real time study, several	Pass
Stability- Product Shelf Life(18°C to 21°C)		lots tested. Values within±18%

Summary Table:

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Stability protocols, with acceptance criteria, for the Detectabuse® Liquid Controls Urine for ongoing stability testing of on-market product lots

Additional on-going stability studies are done on random lots of each formulation to ensure continued performance; customer satisfaction surveys are also conducted quarterly to receive feedback on product performance. Negative customer feedback on product performance will trigger retesting if warranted after investigation. Controls are tested initially, and if no negative feedback, repeated every 6 months until endpoint of study, unless otherwise indicated in a specific study protocol. A normal testing protocol is designed to mimic the end users use of the product in accordance with the package insert instructions.

d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable
1. Comparison studies:
- a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:
Not applicable
1. Clinical studies:
- a. Clinical Sensitivity: Not applicable
- b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):
Page |

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Not applicable

4. Clinical cut-off:

Clinical cut-off levels are determined by the SAMHSA (Substance Abuse and Mental Health Services Administration) or by individual Laboratory Directors.

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Expected values/Reference range are formulated anywhere between -80% of the confirmation test cutoff concentrations and 4X of the initial test cutoff concentrations: All drugs (ng/mL) except acetaminophen and ethanol (mg/dl)

Constituents	-80%Confirmatory	CutoffInitial/Confirmatory	4X Initial
Delta-9-THC-COOH	3	50/15	200
Cannabinoids	3	50/15	200
Benzoylecgonine	20	150/100	600
Phencyclidine (PCP)	5	25/25	100
Opiates (Low)	60	300/300	1200
Opiates(High)	400	2000/2000	8000
Opiates (Low Opiates)	60	300/300	1200
Opiates (High Opiates)	400	2000/2000	8000
Morphine (Low Opiate)	60	300/300	1200
Codeine (Low Opiate)	60	300/300	1200
Morphine (High Opiate)	400	2000/2000	8000
Codeine (High Opiate)	400	2000/2000	8000
Amphetamines	100	500/250	2000
Amphetamine	100	500/250	2000
Methamphetamine	100	500/250	2000
Barbiturates	60	400/300	1600
Secobarbital, Phenobarbital, Butalbital	60	500/300	2000
Benzodiazepines	60	500/300	2000
Oxazepam, Lorazepam, Nordiazepam	60	300/300	1200
Methadone, EDDP	60	300/300	1200
Methaqualone	60	300/300	1200
Propoxyphene	60	300/300	1200
Nortriptyline	100	1000/500	4000
MDMA, MDEA, MDA	50	500/250	2000
Oxycodone	10	100/50	400
Hydrocodone	20	300/100	1200
Buprenorphine	1	10/5	40
Buprenorphine Glucuronide	1	12.5/5	50
6-MAM	1	10/5	40
Cotinine	10	200/50	800
Fentanyl	0.2	25/1.0	100
Tramadol	10	100/50	400
Lysergic Acid	0.1	0.5/0.5	2.0
Acetaminophen (mg/dL)	1	10/5	40
Ethanol (mg/dL)	10	100/50	400

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N. Summary Statement:

Detectabuse® controls are stabilized with the same proprietary method as our other stabilized Detectabuse® liquid urine controls and have tested to be equivalent in performance and stability. The above substantial equivalence comparison demonstrates that the stabilized Detectabuse® control is as safe and effective and performs the same as the predicate device.

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.