(110 days)
Not Found
No
The device description and performance studies focus on the chemical composition and stability of oral fluid controls for toxicology testing, with no mention of AI or ML.
No
The device is described as an in vitro diagnostic quality control for monitoring the precision of laboratory oral fluid toxicology testing, not for treating or diagnosing any medical condition in a patient.
No
Explanation: The "Intended Use" section explicitly states that the controls are "intended for in vitro diagnostic use only as quality controls to monitor the precision of laboratory oral fluid toxicology testing procedures." This indicates they are used to verify the accuracy of other diagnostic devices, not to directly diagnose a patient's condition.
No
The device is a liquid oral fluid control, which is a physical substance used for quality control in laboratory testing. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the controls are "intended for in vitro diagnostic use only".
- Purpose: The controls are used to "monitor the precision of laboratory oral fluid toxicology testing procedures" and "provide an estimation of the precision of a device test system, and to detect and monitor systematic deviations from accuracy". This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details the composition and purpose of the controls in the context of laboratory testing.
- Anatomical Site: The controls are designed for use with "Oral Fluid", which is a specimen derived from the human body.
- Intended User / Care Setting: The intended user is a "laboratory", which is a typical setting for IVD use.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K103227) indicates that this device is being compared to a previously cleared IVD by a regulatory body like the FDA.
All of these factors strongly indicate that the Salivabuse® liquid oral fluid controls are intended and function as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: 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.
Key Results:
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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)
-
- 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 - 1997
r
Product Code | Province of a consistent of any of a series of
Classification
、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 of
Same |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DIF | ass
reserved | 21 CFR 862 3280 | I oxicology |
1
5. Substantial Equivalence Information:
1. Predicate device A
Predicate K number K103227
: Oratect®Check Saliva/Oral Fluid Controls
(Positive and Negative)
6a. 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.
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:
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.
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
2
10. Comparison of Technological Characteristics
Similarities and differences between new and predicate devices.
| Similarities | ||||||
|---|---|---|---|---|---|---|
| Device | Predicate Device (K103227) | |||||
| Oratect®Check Saliva/Oral Fluid | ||||||
| Controls (Positive and Negative) | New Device (K132688) | |||||
| Salivabuse® Liquid Oral Fluid | ||||||
| Control | ||||||
| Intended Use | Quality control oral fluid to monitor | |||||
| the performance of laboratory | ||||||
| toxicology screening procedures. For | ||||||
| in vitro diagnostic use only | Quality control oral fluid to monitor the performance | |||||
| of laboratory toxicology screening procedures. For | ||||||
| in vitro diagnostic use only | ||||||
| ·Form | Liquid | Liquid | ||||
| Differences | ||||||
| Target Drug | ||||||
| Levels | ||||||
| (See package | ||||||
| inserts) | 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 the | |||||
| expiration date (24 months) when | ||||||
| stored at -150C. | The controls are stable until the expiration date (12 | |||||
| months) when stored -10℃ to -20℃ (frozen) or 20- | ||||||
| 8°C (refrigerated). | ||||||
| Storage | ||||||
| Opened | Opened | |||||
| The opened vial controls are stable | ||||||
| for 7 days stored at 40C. | The opened vial controls are stable for 31 days stored at 2- | |||||
| 8°C. |
.
3
| Analytes | |
|---|---|
| Amphetamines(Amphetamine), | |
| Methamphetamines(Methamphetamine), | |
| Cocaine, Benzoylecgonine, Opiates, | |
| PCP, Cannabinoids(THC) | The same measurands from predicate device K103227 |
| with the additional measurands: | |
| Methadone, | |
| Cotinine | |
| Ethanol, | |
| Benzodiazepines | |
| Barbiturates |
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.
4
Stability Summary Table:
ﺑ
| Evaluation Parameter for
Stability of Product Shelf Life
(Temperature)
(Open/Closed Vial) | Specifications for Real time study.
of vials tests
ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
length of study
2.
3. Conclusion | Acceptance
Criteria
Positive controls test
positive and Negative
controls test negative.
Results:
Pass / Fail |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Refrigerated Temperature
(2-8°C) (Open Bottle) | 3 lots/3 vials each tested
1.
T-0, 31 days.
2.
Positive controls tested positive and Negative
3.
controls tested negative. | PASS |
| Refrigerated Temperature
(2-8°C) (Close Bottle) | 1. 3 lots/3 vials each tested for the drugs listed in
submission periodically for 1 year, study ongoing.
Positive controls tested positive and Negative
controls tested negative. | PASS |
| Frozen Temperature
(-10°C to -20°C) (Close vial) | 1. 3 lots/3 vials each tested for the drugs listed in
submission periodically for 1 year, study ongoing.
Positive controls tested positive and Negative controls
tested Negative. | PASS |
5
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.
6
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.
7
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
8
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)
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.
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)