T.B.Q.

K962739 · Convatec, A Division of E.R. Squibb & Sons · LRJ · Oct 7, 1996 · General Hospital

Device Facts

• Record ID: K962739
• Device Name: T.B.Q.
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: LRJ · General Hospital
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6890
• Device Class: Class 1

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 surfaces in healthcare facilities.

Device Story

T.B.Q. is a liquid chemical germicide; active ingredients are quaternary ammonium chloride compounds. Used in healthcare facilities for disinfection of hard inanimate surfaces and reusable non-critical medical devices. Applied by healthcare personnel to surfaces to reduce microbial load. Effectiveness demonstrated via AOAC germicidal, tuberculocidal, fungicidal, and virucidal tests. Benefits include inactivation of pathogens such as S. aureus, S. choleraesuis, Ps. aeruginosa, T. mentagrophytes, Influenza A2, Herpes simplex, Vaccinia, Adenovirus Type 5, and HIV-1.

Clinical Evidence

Bench testing only. Passed AOAC Germicidal Use-Dilution Test, Tuberculocidal Test, Fungicidal Test, and Virucidal Qualification Test against specified pathogens (S. aureus, S. choleraesuis, Ps. aeruginosa, T. mentagrophytes, Influenza A2, Herpes simplex, Vaccinia, Adenovirus Type 5, and HIV-1) at specified dilutions in hard and distilled water.

Technological Characteristics

Liquid chemical germicide; active ingredients: quaternary ammonium chloride compounds. Formulated for dilution in water (1:64 or 1:128).

Indications for Use

Indicated for inactivation of bacteria, fungi, and viruses on hard inanimate surfaces and reusable non-critical medical devices in healthcare facilities.

Regulatory Classification

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.

Predicate Devices

• Tor Germicidal Cleaner (Huntington Laboratories)
• Quat-Syl 256 (National Laboratories)
• Futron 25 (Hysan Corp.)

Submission Summary (Full Text)

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OCT - 7 1996
510(k) Summary
K962739

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 [phone]

Description: T.B.Q. is a liquid chemical germicide utilizing quaternary 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 surfaces 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 germicides utilizing quaternary ammonium chloride compounds as active ingredients to inactivate specific bacteria, fungi, and viruses on hard inanimate surfaces.

Safety Data: Acute Oral $\mathrm{LD}_{50}$ (Rats) = 1,900 mg/kg
Acute Inhalation $\mathrm{LC}_{50} = >2.2\ \mathrm{ml/ft^3}$
Dermal Irritation (Rabbit) neat = Primary Irritation Index of 5.38 (Draize Scale), Moderate Irritation
Dermal Irritation (Rabbit) 1:64 aqueous dilution = Primary Irritation 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. choleraesuis 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 A$_2$, Herpes simplex, Vaccinia and Adenovirus Type 5
Passes EPA approved Dilution Method in 400 ppm hard water at a 1:64 dilution against the HIV-1 (AIDS) virus.