The Salivabuse® liquid oral fluid controls are intended for in vitro diagnostic use only as quality controls to monitor the precision of laboratory oral fluid toxicology testing procedures for the analytes listed in the package insert. The Salivabuse ® controls are available as multi-constituent and single constituent controls.

Device Description

The Salivabuse ® multi-constituent and the Salivabuse® single constituent 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. Salivabuse® liquid oral fluid controls are available in Negative, Cutoff -60%, Cutoff -50%, Cutoff -30%, Cutoff -25%, Cutoff, Cutoff +2.5%. Cutoff +50%. 2X Cutoff and 3X Cutoff levels. Each bottle contains stabilized synthetic oral fluid. Positive controls have been gravimetrically spiked with authentic reference drug standards and/or appropriate metabolites. Negative controls are certified negative by combination of immunoassay, GC/MS and/or LC/MS for the constituents listed on our target sheets. The products contain either sodium azide or a proprietary preservative compatible with products that are adversely affected by sodium azide.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study conducted for the Salivabuse® Liquid Oral Fluid Control, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Evaluation Parameter for Stability of Product Shelf Life (Temperature) (Open/Closed Vial)	Acceptance Criteria	Reported Device Performance
Refrigerated Temperature (2-8°C) (Open Bottle)	Positive controls test positive and Negative controls test negative. For value assignment, GC/MS analytes within ± 20% of target value at end of expiration date.	PASS: Data supports the 31-day open bottle stability claim at 2-8℃ for all analytes in the lots evaluated. All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative.
Refrigerated Temperature (2-8°C) (Closed Bottle)	Positive controls test positive and Negative controls test negative. For value assignment, GC/MS analytes within ± 20% of target value at end of expiration date.	PASS: All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative for 1 year for the drugs listed in submission (study ongoing).
Frozen Temperature (-10°C to -20°C) (Closed Vial)	Positive controls test positive and Negative controls test negative. For value assignment, GC/MS analytes within ± 20% of target value at end of expiration date.	PASS: All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative for 1 year for drugs listed in submission (studies ongoing).
Value Assignment (Immunoassay and Single-use devices)	Positive controls test positive and negative product tests negative.	PASS: All analytes tested met these acceptance criteria.
Value Assignment (GC/MS at end of expiration date)	Analytes were within ± 20% of target value.	PASS: All analytes met the acceptance criteria for the Salivabuse® controls.

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

The text describes stability testing and value assignment for the Salivabuse® controls.

Stability Studies (Test Set):
- For each temperature condition (Refrigerated Open, Refrigerated Closed, Frozen Closed), 3 lots were tested.
- From each lot, 3 vials were tested.
- This means a minimum of 9 vials were used per temperature condition (3 lots * 3 vials).
- Data Provenance: The studies are described as "real time and accelerated stability testing" and "ongoing," suggesting a prospective nature. The manufacturer, Biochemical Diagnostics, Inc., is based in Edgewood, NY, USA, which implies the data provenance is likely from the USA, although specific geographic locations for testing labs are not explicitly stated beyond "Certified Independent laboratories."
Value Assignment (Test Set):
- An "initial production batch is sampled from the beginning, middle and end of production."
- "Single or multiple samples were analyzed." The exact number of samples is not specified.
- Data Provenance: Similar to stability, likely USA, from "Certified Independent laboratories using...SAMHSA licensed laboratories or CAP inspected and certified laboratories."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "experts" in the traditional sense (e.g., radiologists) is not applicable here. This device (Salivabuse®) is a quality control material, not a diagnostic imaging or interpretive device.

Ground truth for quality control materials is established through analytical methods and certified reference standards.
For value assignment and stability testing, the "ground truth" and verification of performance were established through:
- Certified Independent laboratories
- SAMHSA licensed laboratories or CAP inspected and certified laboratories
- These laboratories use established analytical techniques:
  - GC/MS (Gas Chromatography/Mass Spectrometry)
  - LC/MS (Liquid Chromatography/Mass Spectrometry)
  - Immunoassay analyzers
  - FDA cleared drugs of abuse screening devices
The qualifications of the personnel performing these analyses at these certified laboratories would align with standard laboratory practices for toxicology and clinical chemistry, but specific titles (e.g., "toxicologist with 10 years of experience") are not provided. The certification of the laboratories (SAMHSA, CAP) inherently implies qualified personnel and accredited procedures.

4. Adjudication Method for the Test Set

Adjudication, in the sense of resolving discrepancies between multiple human reviewers, is not applicable here. The "adjudication" for this type of device is inherent in the analytical methods and the acceptance criteria:

For Immunoassay and single-use devices, the outcome is binary: positive or negative.
For GC/MS and LC/MS, the outcome is quantitative, with acceptance criteria defined as being within a certain percentage of the target value.
The multiple lots and vials tested provide a form of internal validation, where consistent results across these samples confirm the stability and accuracy.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where accuracy depends on human interpretation (e.g., image-reading AI). The Salivabuse® control is an in vitro diagnostic quality control material, not a diagnostic device requiring human interpretation in its intended use.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

This question is also not applicable in the context of this device. The Salivabuse® control is itself a "standalone" product (a liquid control material). Its performance is evaluated through its physical and chemical stability and its ability to elicit expected analytical results when run on various testing platforms (immunoassay, GC/MS, LC/MS). There is no "algorithm" to evaluate in isolation from human input.

7. The Type of Ground Truth Used

The ground truth for the Salivabuse® control material is established through:

Analytical Chemistry and Reference Standards:
- Gravimetric spiking with authentic reference drug standards and/or appropriate metabolites.
- Purity determination using analytical tools including GC/MS or NMR.
- Balances calibrated with weights traceable to National Institute of Standards and Technology (NIST).
- Certified negative by combination of immunoassay, GC/MS and/or LC/MS for negative controls.
- Confirmed by quantitative GC/MS and/or LC/MS performed by SAMHSA licensed or CAP inspected/certified laboratories.

This is a form of analytical ground truth derived from precise chemical preparation and validated analytical methods.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this device. Salivabuse® is a quality control material whose properties are precisely manufactured and then verified. It is not an AI/ML algorithm that requires training data.

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

As there is no training set for this device, this question is not applicable.

Summary

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Safety and effectiveness as required by 21 CFR 807.92

This summary of the 510K Safety and effectiveness information is being submitted in accordance with the requirements 21 CFR 807.92

DEC 16 2013

1A. 510(k) Number: K132688

Date of revised Summary Preparation December 11, 2013

B. Purpose for Submission: New Device (Traditional 510K)
1. Submitter name and address:

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

SBD #126040

Contact

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

3. Proprietary and Established Names:

Product trade name: Salivabuse® Liquid Oral Fluid Control Established Names Include: Salivabuse® Liquid Control Oral Fluid Salivabuse® Liquid Control Oral Fluid, AU/NZ

4. Regulatory Information:

Classification name: Clinical Toxicology Control Material

1977 - 1997rProduct Code	Province of a consistent of any of a series ofClassification、イスターのアイデント、アイティアのアイテム、アイテリアのアイティアアイティースです。アイア	1. 19, 19, 16, 19, 19, 19, 19, 19, 19, 19,- 15..Regulation Section Panel	and and in the may and the may and the research******************************************************************************************************************************************************************************And and the state of the same ofSame
DIF	assreserved	21 CFR 862 3280	I oxicology

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5. Substantial Equivalence Information:

1. Predicate device A

Predicate K number K103227

: Oratect®Check Saliva/Oral Fluid Controls

(Positive and Negative)

6a. Device Description:

b. Measurand:

Quality control material for Oral Fluid testing of Amphetamines, Methamphetamines, Cocaine, Benzoylecgonine, Opiates, PCP, Cannabinoids, Barbiturates, Benzodiazepines, Methadone, Cotinine, and Ethanol

7. Intended Use:

8. Special conditions for use statement:

Salivabuse® liquid oral fluid controls have been designed for in vitro diagnostic use only. 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.

9. Special instrument requirements: None

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10. Comparison of Technological Characteristics

Similarities and differences between new and predicate devices.

Similarities
Device	Predicate Device (K103227)Oratect®Check Saliva/Oral FluidControls (Positive and Negative)	New Device (K132688)Salivabuse® Liquid Oral FluidControl
Intended Use	Quality control oral fluid to monitorthe performance of laboratorytoxicology screening procedures. Forin vitro diagnostic use only	Quality control oral fluid to monitor the performanceof laboratory toxicology screening procedures. Forin vitro diagnostic use only
·Form	Liquid	Liquid
Differences
Target DrugLevels(See packageinserts)	Negative, Cutoff, Cutoff +50%, Cutoff -50%。	Negative, Cutoff -60%, Cutoff +/-50%, -30%, Cutoff +/-25%, Cutoff, 2X Cutoff, 3X Cutoff
Matrix	Synthetic oral fluid	Stabilized synthetic oral fluid.
Storage	Unopened	Unopened
Unopened	The controls are stable until theexpiration date (24 months) whenstored at -150C.	The controls are stable until the expiration date (12months) when stored -10℃ to -20℃ (frozen) or 20-8°C (refrigerated).

StorageOpened	OpenedThe opened vial controls are stablefor 7 days stored at 40C.	The opened vial controls are stable for 31 days stored at 2-8°C.

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Analytes
Amphetamines(Amphetamine),Methamphetamines(Methamphetamine),Cocaine, Benzoylecgonine, Opiates,PCP, Cannabinoids(THC)	The same measurands from predicate device K103227with the additional measurands:Methadone,CotinineEthanol,BenzodiazepinesBarbiturates

Performance validation studies were conducted using the following methods:

GC/MS 1)
LC/MS 2)
Immunoassay Screening (immunoassay analyzers and/or immunoassay single use screening devices) 3)

11. Summary of Stability Studies

Stability Protocol:

As part of our ongoing Quality System. Biochemical Diagnostics performs real time and accelerated stability testing on our controls to verify the performance claims in our package inserts.

Multi-Constituent controls were tested, Refrigerated (2-8°C), and Frozen (-10 to -20°C). Unopened controls are tested at Time "0" and then repeated on freshly opened vials at the end point of study. Opened vial study was conducted by opening vials to remove an aliquot of control to simulate customer usage and sampling the same vial at the end point of the study. At least 3 different vials from three different lots are tested for each temperature condition.

Protocol - Open Vial (2-8ºC) Stability

Multiple bottles from three lots of individual or multi-constituent Salivabuse® controls were pulled from beginning, middle, and end of production, set aside, and unopened bottles were assayed at time of manufacturing and opened bottles again tested at 31 days.

Protocol - Closed Vial (2-8ºC) Stability

Multiple bottles from three of individual or multi-constituent Salivabuse® controls were pulled from beginning, middle, and end of production , set aside and unopened bottles were assayed at time of manufacturing and again periodically. Studies are ongoing and sent for assay until expiration date. Refrigerated temperature on unopened vial Salivabuse® controls was sampled and tested at peroiodically for one year for drugs listed in submission, studies ongoing.

Protocol - Closed Vial (-10℃ to -20℃) Stability

Multiple bottles from three lots of individual or multi-constituent Salivabuse® controls were pulled from beginning, middle, and end of production , set aside and frozen within a temperature range of -10°C to -20°C. Unopened bottles were sampled and tested at periodically for the first year for, drugs listed in submission, studies ongoing.

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Stability Summary Table:

ﺑ

Evaluation Parameter forStability of Product Shelf Life(Temperature)(Open/Closed Vial)	Specifications for Real time study.# of vials testsـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــlength of study2.3. Conclusion	AcceptanceCriteriaPositive controls testpositive and Negativecontrols test negative.Results:Pass / Fail
Refrigerated Temperature(2-8°C) (Open Bottle)	3 lots/3 vials each tested1.T-0, 31 days.2.Positive controls tested positive and Negative3.controls tested negative.	PASS
Refrigerated Temperature(2-8°C) (Close Bottle)	1. 3 lots/3 vials each tested for the drugs listed insubmission periodically for 1 year, study ongoing.Positive controls tested positive and Negativecontrols tested negative.	PASS
Frozen Temperature(-10°C to -20°C) (Close vial)	1. 3 lots/3 vials each tested for the drugs listed insubmission periodically for 1 year, study ongoing.Positive controls tested positive and Negative controlstested Negative.	PASS

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Conclusions

Protocol - Open Vial (2-8°C) Stability Conclusion:

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

Protocol - Closed Vial (2-8℃) Stability

Conclusion:

All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative for 1 year for the drugs listed in submission(study ongoing).

Protocol - Closed Vial (-10℃ to -20℃) Stability

Conclusion:

Multiple studies were conducted using several different lots. All analytes tested passed specifications, Positive controls tested positive and Negative controls tested negative for 1 year for drugs listed in submission (studies ongoing).

12. Summary of Value Assignment

The following procedure is used for value assignment

a. Assay Methodology used to assign values:
Certified Independent laboratories using the following test methods: GC/MS, LC/MS, Immunoassay analyzers, and single-use FDA cleared drugs of abuse screening devices were used for value assignment to ensure control solutions contain appropriate analyte levels.
Value assignment Criteria: b.
An initial production batch is sampled from the beginning, middle and end of production. Single or multiple samples were analyzed by quantitative GC/MS and/or LC/MS (using SAMHSA licensed laboratories or CAP inspected and certified laboratories), and immunoassay analyzers. The Salivabuse® controls were also tested on single-use FDA cleared drugs of abuse screening devices from several manufacturers. Acceptance criteria for immunoassay and single-use devices was that positive controls test positive and negative product tests negative.

Acceptance criteria for GC/MS at the end of its expiration date was that analytes were within ± 20% of target value. All analytes met the acceptance criteria for the Salivabuse® controls.

Traceabilitv

The controls are manufactured using reference standards supplied by commercial vendors. Accuracy is certified by purity determination using analytical tools including GC/MS, or NMR. Gravimetric preparation is accomplished using balances calibrated with weights that are traceable to National Institute of Standards and Technology (NIST).

14. Conclusion

Testing results indicate that the proposed device is substantially equivalent to the Predicate device Oratect®Check Saliva/Oral Fluid Controls K103227 (Positive and Negative) with the additional measurands: Methadone, Cotinine, Ethanol, Benzodiazepines and Barbiturates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which includes a stylized representation of a human figure embracing a globe. The emblem is positioned to the right of the department's name, which is written in a circular fashion around the emblem. The text is in a sans-serif font and is black.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 16, 2013

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

Re: K132688

Trade/Device Name: Salivabuse® Liquid Oral Fluid Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: I, reserved Product Code: DIF Dated: November 1, 2013 Received: November 8, 2013

Dear Mr. 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 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.

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Page 2-Mr. Panetz

ﻧﺴﺮ ﺍﻟﻤﺴﺎﺑﻖ ﺍﻟﻤﺮ

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Small Manufacturers, International and Consumer Assistance 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Carol C. Benson -S for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

12.000

K132688

Device Name Salivabuse Liquid Oral Fluid Control

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

O Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE CHILING OF FOR FOR FOR FOR FOR AND CONTRACTORIAL CONTROLLED Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Denise Johnson-lyles -S

FORM FDA 3881 (9/13)

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.