(193 days)
K# 923133, K# 964015, K# 962718
Not Found
No
The device description and performance studies detail a chemical reaction-based test that produces a color change based on enzyme activity. There is no mention of computational analysis, algorithms, or learning processes.
No
This device is an in vitro diagnostic test designed to aid in the diagnosis of bacterial vaginosis by detecting sialidase activity in vaginal fluid samples, not to treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "BVBLUE™ is indicated for use in women suspected of having Bacterial Vaginosis (BV) infection... as an aid in the diagnosis of BV infection." It also states "For In Vitro Diagnostic Use Only." These statements confirm its diagnostic purpose.
No
The device is an in vitro diagnostic test kit that relies on chemical reactions and color changes to detect an enzyme. It includes physical components (testing vessels, developer solution) and does not describe any software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For In Vitro Diagnostic Use Only."
- Intended Use: The intended use is to detect sialidase activity in vaginal fluid specimens as an aid in the diagnosis of Bacterial Vaginosis (BV) infection. This involves testing biological samples outside of the body to provide information for diagnosis.
- Device Description: The device contains reagents (chromogenic substrate and developer solution) designed to react with components in the vaginal fluid specimen to produce a detectable signal (color change) related to the presence of sialidase enzyme. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document describes performance studies using clinical samples (vaginal fluid specimens) and comparing the results to established diagnostic methods for BV (Amsel Criteria, Gram's stain, etc.). This demonstrates the device's use in a diagnostic context.
- Intended User/Care Setting: It is indicated for professional use in point-of-care and physician's offices, which are typical settings for diagnostic testing.
N/A
Intended Use / Indications for Use
BVBLUE is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp.
BVBLUE is indicated for use in women suspected of having Bacterial Vaginosis (BV) infection, e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid in the diagnosis of BV infection. BVBLUE test results should be considered in conjunction with other clinical and patient information (see Limitations of the Procedure).
For In Vitro Diagnostic Use Only. BVBLUE is indicated for professional use only and may be used at the point of care and/or in physician's offices. It is not intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
MXB
Device Description
The BVBLUE Test contains a chromogenic substrate of sialidase enzyme, IBX-4041. The chromogenic substrate is provided in each of the BVBLUE Testing Vessels as a solution containing 0.25 mg IBX-4041 in 0.5 mL aqueous potassium acetate solution (49.0 mg/mL; 0.5 M, pH 5.5-6.0). When the solution containing the solubilized chromogenic substrate is exposed to sialidase enzyme, the substrate is hydrolyzed to yield sialic acid and IBX-4050. Upon the addition of one or more drops of the BVBLUE Developer Solution [an aqueous sodium hydroxide solution (40 mg/mL; 1.0 M; pH>11.0)], IBX-4050 exhibits an intense blue color. In the absence of sialidase enzyme, the chromogenic substrate is not hydrolyzed and exhibits a yellow color upon the addition of one or more drops of the BVBLUE Developer Solution.
Materials Provided:
10 BVBLUE Units per Package:
- Ten (10) BVBLUE Testing Vessels each containing 0.25 mg IBX-4041 component in 0.5 mL of an aqueous potassium acetate buffer solution (49.0 mg/mL; 0.5 M; pH 5.5-6.0).
- One (1) BVBLUE Developer Solution Tube containing 0.5 mL of an aqueous sodium hydroxide solution (40.0 mg/mL; 1.0 M; pH>11.0).
- Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use only and may be used at the point of care and/or in physician's offices.
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
BVBLUE was evaluated using analytical samples of sialidase enzyme (Sigma Chemical Co.).
Sample size: 207 replicates (69 with sialidase enzyme levels ≥0.25 µg and 138 with
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(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 § 866.9.
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MAY 1 5 2000
EXTUBIT # I Page 1 of 8
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:__K993732/S1
1. Submitter's Identification:
Gryphus Diagnostics, L.L.C. 2800 Milan Court, Suite 235 Birmingham, AL 35211 Contact Person: Stephen C. Johnson, Ph.D.
Data Summary Prepared: October 20, 1999
Name of the Device: 2.
BVBLUETM
3. Predicate Device Information:
-
- Affirm/VP Identifiaction Test for Gardnerella vaginalis and Trichomonas vaginalis, K# 923133, Microprobe Inc.
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- Indicard® Test, K# 964015, Litmus Concepts, Inc.
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- FemExam® TestCard™ pH and Amines Tests, K# 962718, Litmus Concepts, Inc.
Device Description: র্বা
The BVBLUE™ Test contains a chromogenic substrate of sialidase enzyme, IBX-4041. The chromogenic substrate is provided in each of the BVBLUE™ Testing Vessels as a solution containing 0.25 mg IBX-4041 in 0.5 mL aqueous potassium acetate solution (49.0 mg/mL; 0.5 M, pH 5.5-6.0). When the solution containing the solubilized chromogenic substrate is exposed to sialidase enzyme, the substrate is hydrolyzed to yield sialic acid and IBX-4050. Upon the addition of one of more drops of the BVBLUE™ Developer Solution [an aqueous sodium hydroxide solution (40 mg/mL; 1.0 M; pH>11.0)], IBX-4050 exhibits an intense blue color. In the absence of sialidase enzyme, the chromogenic substrate is not hydrolyzed and exhibits a vellow color upon the addition of one or more drops of the BVBLUE'M Developer Solution.
Materials Provided:
10 BVBLUE™ Units per Package:
1
- Ten (10) BVBLUE™ Testing Vessels each containing 0.25 mg IBX-4041 . component in 0.5 mL of an aqueous potassium acetate buffer solution (49.0 mg/mL; 0.5 M; pH 5.5-6.0).
- One (1) BVBLUE™ Developer Solution Tube containing 0.5 mL of an . aqueous sodium hydroxide solution (40.0 mg/mL; 1.0 M; pH>11.0).
- Instructions for Use .
ર. Intended Use:
BVBLUE™ is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp.
BVBLUE™ is indicated for use in wornen suspected of having Bacterial Vaginosis (BV) infection, e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid in the diagnosis of BV infection. BVBLUE™ test results should be considered in conjunction with other clinical and patient information (see Limitations of the Procedure).
For In Vitro Diagnostic Use Only. BVBLUE™ is indicated for professional use only and may be used at the point of care and/or in physician's offices. lt is not intended for home use.
6. Comparisons to Predicate Devices:
Affirm/VP (manufactured by Becton Dickinson) evaluates patient vaginal fluid samples for the presence of Gardnerella vaginalis nucleic acid. Gardnerella vaginalis is a microorganism causative of bacterial vaginosis. Using this test, a patient vaginal fluid sample is obtained with a sterile cotton swab. A portion of the sample is transferred to a tube containing a lysis solution, thoroughly mixed, incubated at 85 °C for 10 minutes, and treated with a buffer solution. A portion of the resulting mixture is transferred to a Processor and then reacted for a period of 30 minutes to provide an identification of Gardnerella vaginalis nucleic acid. A positive indication for Gardnerella vaginalis nucleic acid is indicative of bacterial vaginosis in patients presenting bacterial vaginosis-like symptoms.
Indicard™ test (manufactured by Litmus Concepts, Inc.) evaluates patient vaginal fluid specimens for the presence of Gardnerella vaginalis proline imino peptidase enzyme activity. Gardnerella vaginalis is a microorganism
2
causative of bacterial vaginosis. Using this test, a patient vaginal fluid sample is obtained with a sterile cotton swab. A portion of the sample is then transferred to the Indicard™ test to evaluate for the presence of Gardnerella vaginalis. A positive indication for Gardnerella vaginalis oroline imino peotidase enzyme activity is indicative of bacterial vaginosis in patients presenting bacterial vaginosis-like symptoms.
FemExam® TestCard™ (manufactured by Litmus Concepts, Inc.) evaluates patient vaginal fluid samples for elevated pH (i.e., pH >4.7) and for the presence of volatile amines in patient vaginal fluid samples. The pH and amine tests are two components of the Amsel Criteria, the Gold Standard method of clinically diagnosing patient vaginal fluid samples for bacterial vaginosis. Using this test, a patient vaginal fluid sample is obtained with a sterile cotton swab. A portion of the sample is first transferred to a section of the FemExam® TestCard™ to evaluate for elevated pH. A second portion of the sample is transferred to the card to evaluate for the presence of volatile amines. A positive indication in both the pH and amines tests is indicative of bacterial vaginosis in patients presenting bacterial vaginosis-like symptoms.
BVBLUE TM (manufactured by Gryphus Diagnostics, L.L.C.) evaluates patient vaginal fluid samples for sialidase activity, an enzyme produced by bacterial pathogens associated with Bacterial Vaginosis (BV) such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. Using this test, a patient vaginal fluid sample is obtained with a sterile cotton swab. A portion of the sample is then transferred to the BVBLUE™ test and incubated for 10 minutes at 37 ℃ to provide identification of sialidase enzyme activity. A positive indication for sialdiase enzyme activity is indicative of bacterial vaginosis in patients presenting bacterial vaginosis-like symptoms.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equilivance are as follows:
BVBLUE™ was evaluated using analytical samples of sialidase enzyme (Sigma Chemical Co.). The BVBLUE™ Test produces a positive result when the vaginal fluid contains ≥0.25 µg sialidase enzyme [i.e., ≥ 7.64 U (units of enzyme activity)]. This performance was defined in laboratory studies employing coded sialidase solutions containing varying levels of sialidase activity. A total of 207 replicates were evaluated.
3
Of the 207 replicates, a total of 69/207 contained sialidase enzyme levels ≥0.25 ug (33%): and 138/207 contained sialidase enzyme levels Trade Name: BVBlue™ Regulatory Class: I Reserved Product Code: MXB Dated: March 7, 2000 Received: March 7, 2000
Dear Mr. Tsakeris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
9
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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EXHIBIT B Page 1 of 1
510(k) Number (if known): K993732
Device Name: BV BLUE™
Indications for Use:
BV BLUEm is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp.
BV BLUE™ is indicated for use in women suspected of having Bacterial Vaginosis (BV) infection, e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid in the diagnosis of BV infection. BV BLUE™ test results should be considered in conjunction with other clinical and patient information (see Limitations of the Procedure)
For In Vitro Diagnostic Use Only. BV9LUE™ is indicated for professional use only and may be used at the point of care and/or in physician's offices. It is not intended for home-use.
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993732
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
い OR Over-The-Counter Use Prescription Use Format 1-2-96) (Per 21 CFR 801.109)