(84 days)
Not Found
Not Found
No
The device is a liquid chemical germicide and the description focuses on its chemical composition and germicidal effectiveness, with no mention of AI or ML.
No.
T.B.Q. is a liquid chemical germicide used to inactivate specific bacteria, fungi, and viruses on hard inanimate surfaces, including non-critical medical devices and environmental surfaces. It is not applied to a patient for diagnosis, treatment, or prevention of disease.
No
Explanation: The device is a liquid chemical germicide used to inactivate bacteria, fungi, and viruses on surfaces; it does not diagnose medical conditions.
No
The device description clearly states it is a liquid chemical germicide, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental surfaces in healthcare facilities." This describes a disinfectant for surfaces and equipment, not a test performed on biological samples from a patient to diagnose a condition.
- Device Description: It's a "liquid chemical germicide." This aligns with a disinfectant, not an IVD.
- Performance Studies: The performance studies focus on the germicidal, tuberculocidal, fungicidal, and virucidal effectiveness against various microorganisms on surfaces. This is typical testing for disinfectants, not IVDs which would involve analytical and clinical performance on patient samples.
IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
T.B.Q. is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental suffaces in healthcare facilities.
Product codes
Not Found
Device Description
T.B.Q. is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.
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
healthcare facilities
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)
Safety Data: Acute Oral LDso (Rats) = 1,900 mg/kg
Acute Inhalation LC50 = >2.2 ml/ft3
Dermal Irritation (Rabbit) neat = Primary Irritation Index of 5.38 (Draize Scale), Moderate Irritation
Dermal Irritation (Rabbit) 1:64 aqueous dilution = Primary Initation Index of 0.09 (Draize Scale), Barely Perceptible Irritation
Eye Irritation (Rabbit) neat = Corrosive
Eye Irritation (Rabbit) 1:64 aqueous dilution = No irritation
Dermal Sensitization (Guinea Pig) 2.5% w/w aqueous solution = Negative as sensitizer
Effectiveness Data: Germicidal: Passes AOAC Germicidal Use-Dilution Test in 400ppm hard water at a 1:64 dilution and in distilled water at a 1:128 dilution against S. aureus, S. choleraesus and Ps. aeruginosa.
Tuberculocidal: Passes AOAC Tuberculocidal Test at a 1:128 dilution in distilled water. Fungicidal: Passes AOAC Fungicidal Test in 400 ppm hard water at a 1:64 dilution and in distilled water at a 1:128 dilution against T. mentagrophytes.
Virucidal: Passes Virucidal Qualification Test in 400 ppm hard water at a 1:64 dilution against Influenza An, Herpes simplex, Vaccinia and Adenovirus Type S
Passes EPA approved Dilution Method in 400 ppm hard water at a 1.64 dilution against the HIV-I (ADS) virus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6890 General purpose disinfectants.
(a)
Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.(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 § 880.9.
0
OCT - 7 1996
510(k) Summary
Trade Name: T.B.Q. Common/Usual Name: General Purpose Disinfectant
Submitter Manufacturer. ConvaTec. Division of E.R. Squibb and Sons, Inc. 5035 Manchester Avenue St Louis, MO 63110 Establishment Registration Number: 1940768 Contact: Mike Ebers, Manager Regulatory Affairs (314) 535-1390
Description: T.B.Q. is a liquid chemical germicide utilizing quatinary ammonium chloride compounds as active ingredients.
Intended Use: T.B.Q. is used to inactivate specific bacteria, fungi and viruses on hard inanimate surfaces including reusable non-critical medical devices and environmental suffaces in healthcare facilities.
Substantial Equivalence to: (1)Tor Germicidal Cleaner, Huntington Laboratories, (2) Quat-Syl 256, National Laboratories, (3) Futron 25, Hysan Corp.
Comparison to Listed Substantially Equivalent Products: Listed products are also liquid chemical gennicides utilizing quatinary ammonium chloride compounds as active ingredients to inactivate specific bacteria, fungi, and viruses on hard inanimate surfaces.
Safety Data: Acute Oral LDso (Rats) = 1,900 mg/kg
Acute Inhalation LC50 = >2.2 ml/ft3
Dermal Irritation (Rabbit) neat = Primary Irritation Index of 5.38 (Draize Scale), Moderate Irritation
Dermal Irritation (Rabbit) 1:64 aqueous dilution = Primary Initation Index of 0.09 (Draize Scale), Barely Perceptible Irritation
Eye Irritation (Rabbit) neat = Corrosive
Eye Irritation (Rabbit) 1:64 aqueous dilution = No irritation
Dermal Sensitization (Guinea Pig) 2.5% w/w aqueous solution = Negative as sensitizer
Effectiveness Data: Germicidal: Passes AOAC Germicidal Use-Dilution Test in 400ppm hard water at a 1:64 dilution and in distilled water at a 1:128 dilution against S. aureus, S. choleraesus and Ps. aeruginosa.
Tuberculocidal: Passes AOAC Tuberculocidal Test at a 1:128 dilution in distilled water. Fungicidal: Passes AOAC Fungicidal Test in 400 ppm hard water at a 1:64 dilution and in distilled water at a 1:128 dilution against T. mentagrophytes.
Virucidal: Passes Virucidal Qualification Test in 400 ppm hard water at a 1:64 dilution against Influenza An, Herpes simplex, Vaccinia and Adenovirus Type S
Passes EPA approved Dilution Method in 400 ppm hard water at a 1.64 dilution against the HIV-I (ADS) virus.