(89 days)
Avanti's VDRL antigen and Buffered Saline are intended for use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis. The VDRL slide test is a non-treponemal, micro-flocculation test, that provides both qualitative and semi-quantitative results. The test is for the detection of IgM and IgG anticardiolipin antibodies in serum specimens.
The Venereal Disease Research Laboratory slide test is a test for the detection of syphilis. The test employs an antigen containing cardiolipin, phosphatidylcholine (lecithin), and cholesterol dissolved in ethanol. The antigen is suspended in a buffered saline solution, which flocculates when combined with serum containing IgM and IgG anti-cardiolipin antibodies. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis. The flocculation forms a three-dimensional lattice structure that can be seen at low magnification (10x oculars and 10x objective) with a light microscope.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
Device: Avanti Polar Lipids VDRL Antigen Slide Test Kit
Intended Use: For use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis, a non-treponemal, micro-flocculation test that provides both qualitative and semi-quantitative results to detect IgM and IgG anticardiolipin antibodies in serum.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Implied / Comparator Performance) | Reported Device Performance (Avanti Polar Lipids VDRL Antigen Slide Test Kit) |
|---|---|---|
| Specificity | Not explicitly stated as a numerical acceptance criterion, but the claim of "substantial equivalence" implies that the specificity should be comparable to legally marketed VDRL Antigen Slide Test Kits. The predicate devices are listed as: Becton Dickinson's VDRL Antigen For Syphilis Serology, Cenogenics ADRL/STS Test, Lee Laboratories VDRL Antigen, and Centers for Disease Control and Prevention VDRL Antigen. Performance of these predicates is not given in the document, but it can be inferred that 100% specificity is a very high, desirable performance characteristic. | 100% |
| Sensitivity | Not explicitly stated as a numerical acceptance criterion, but the claim of "substantial equivalence" implies that the sensitivity should be comparable to legally marketed VDRL Antigen Slide Test Kits (as listed above). Performance of these predicates is not given in the document. | 86.5% |
| Reproducibility | Inter-day and intra-day testing should demonstrate consistency. A "maximum inter-day and intra-day difference of one doubling dilution" when tested by the same clinician, and "an end point within two doubling dilutions of the true end point when tested by different clinicians" are the criteria for acceptable reproducibility. This implies that the device should yield consistent qualitative and semi-quantitative results across different testing sessions and operators. | Demonstrated. Maximum inter-day and intra-day difference of one doubling dilution (same clinician). All reactive specimens gave an end point within two doubling dilutions of the true end point (different clinicians). |
| Technological Characteristics (Antigen Composition) | The composition of the Avanti VDRL Antigen (Cardiolipin, Cholesterol, Lecithin dissolved in ethanol) should be comparable to predicate devices. Specific concentrations of Cardiolipin, Cholesterol, and Lecithin (for standard reactivity) are provided for comparison, implying these concentrations define the acceptable range for a VDRL antigen. | Cardiolipin: 0.1 g/L, Cholesterol: 9.0 g/L, Lecithin: sufficient for standard reactivity (1-1.9 g/L) – Comparable to Becton Dickinson, with slight variation in Cardiolipin and Lecithin ranges. |
| Technological Characteristics (Buffered Saline Composition) | The composition of the Avanti Balanced Saline solution (Formaldehyde, Sodium Chloride, Disodium phosphate, Monopotassium phosphate dissolved in deionized water) should be comparable to predicate devices. Specific concentrations for each component are provided. | Formaldehyde: 0.5 mL/L, NaCl: 10.0 g/L, Disodium phosphate: 0.037 g/L, Monopotassium phosphate: 0.170 g/L – Identical to Becton Dickinson. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Specificity and Sensitivity (Performance Data): 100 documented cases of syphilis.
- Sample Size for Reproducibility Data: Not explicitly stated, but “specimens from a blind, coded panel” were used. The number of specimens in this panel is not provided.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "documented cases of syphilis," implying these were existing patient samples with established diagnoses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth is referred to as "documented cases of syphilis," which implies a clinical diagnosis, but the method or personnel establishing this documentation are not detailed. For reproducibility, "different clinicians" were involved, but their qualifications are not given.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the "documented cases of syphilis." The ground truth appears to be based on pre-existing diagnostic records. For reproducibility, results from different clinicians were compared, but no formal adjudication process between them is outlined beyond comparing an end point within two doubling dilutions of the "true end point."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the Avanti Polar Lipids VDRL Antigen Slide Test Kit itself, not on how human readers' performance might improve with or without AI assistance. This device is an antigen for a manual slide test, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, a standalone performance assessment was conducted. The sensitivity and specificity reported are those of the "Avanti Polar Lipids, Inc. VDRL Antigen Slide Test Kit" itself, meaning the kit's ability to react correctly with samples. While a human is involved in observing the flocculation under a microscope, the performance metrics are attributed to the device's ability to yield the correct reaction, forming the basis for a diagnosis. It's a test kit, not an algorithm, so algorithm-specific standalone performance isn't applicable in the modern AI sense. However, the data presented pertains to the device's inherent performance.
7. The Type of Ground Truth Used
The ground truth used for sensitivity and specificity was based on "documented cases of syphilis." This broadly refers to clinical diagnosis or confirmed cases (likely by other established methods for syphilis diagnosis). For reproducibility, a "true end point" was mentioned, which would presumably be a previously established titer for the control specimens in the blind panel.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI components. This device is a traditional in vitro diagnostic (IVD) test kit, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (since it's not an AI/ML device), this information is not applicable.
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Safety and Effectiveness Summary 1.
This 510(k) summary of safety and effectiveness data is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.
-
Submitter: a.
Avanti Polar Lipids, Inc. 700 Industrial Park Drive Alabaster, AL 35007 Tel: (205) 663-2494 (205) 663-0756 Fax: -
Contact: b.
Rowena Shaw, Vice President -
Date Submitted C.
June 22, 1999 -
d. Device Name:
Trade Name: Avanti Polar Lipids VDRL Antigen Slide Test Kit
Common Name: VDRL Antigen Slide Test Kit
Classification Name: ANTIGENS, NON-TREPONEMAL, ALL
- Device Description e.
The Venereal Disease Research Laboratory slide test is a test for the detection of syphilis. The test employs an antigen containing cardiolipin, phosphatidylcholine (lecithin), and cholesterol dissolved in ethanol. The antigen is suspended in a buffered saline solution, which flocculates when combined with serum containing IgM and IgG anti-cardiolipin antibodies. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis. The flocculation forms a three-dimensional lattice structure that can be seen at low magnification (10x oculars and 10x objective) with a light
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microscope.
- f. Intended Use:
Avanti's VDRL antigen and Buffered Saline are intended for use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis. The VDRL slide test is a non-treponemal, micro-flocculation test, that provides both qualitative and semi-quantitative results. The test is for the detection of IgM and IgG anticardiolipin antibodies in serum specimens.
Substantial Equivalence Claim: g. Avanti Polar Lipids, Inc. VDRL Antigen Slide Test Kit is substantially equivalent to the following currently marketed devices:
- VDRL Antigen For Syphilis Serology. Becton Dickinson Microbiology i. Systems, Becton Dickinson and Company, Sparks, MD 21152 USA.
- Cenogenics ADRL/STS Test. Cenogenics Corporation, Morganville, NJ. ii. 07751 USA.
- iii. VDRL Antigen. Lee Laboratories, Inc. 1475 Athens Highway, S.W., Grayson, Georgia 30221 USA.
- VDRL Antigen. Centers for Disease Control and Prevention. Atlanta, GA iv. USA
- Technological Characteristics: h.
Lipid components present in VDRL Antigen
| Component | ConcentrationAvanti Polar Lipids VDRLAntigen | ConcentrationBecton Dickinson's VDRLAntigen |
|---|---|---|
| Cardiolipin derived from oxheart tissue | 0.1 grams / liter | 0.3 grams / liter |
| Cholesterol derived fromlanolin | 9.0 grams / liter | 9.0 grams / liter |
| Lecithin derived from eggyolk | sufficient for standardreactivity (1 - 1.9 grams perliter) | sufficient for standardreactivity (1.8 - 2.0 grams perliter) |
The components listed in the above table are dissolved in ethanol.
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Components present in buffered saline solution
| Component | ConcentrationAvanti Polar LipidsBuffered Saline | Concentration BectonDickinson VDRL BufferedSaline |
|---|---|---|
| Formaldehyde, 37% aqueous,(A.C.S.) | 0.5 ml per liter | 0.5 ml per liter |
| Sodium Chloride (A.C.S.) | 10.0 grams per liter | 10.0 grams per liter |
| Disodium phosphate, anhydrous(A.C.S.) | 0.037 grams per liter | 0.037 grams per liter |
| Monopotassium phosphate,anhydrous (A.C.S.) | 0.170 grams per liter | 0.170 grams per liter |
The components listed in the above table are dissolved in deionized water.
- i. Performance Data
- i. Specificity Data
The specificity of Avanti Polar Lipids, Inc. VDRL Antigen Slide Test Kit was 100% for a sample population of 100 documented cases of syphilis.
-
ii. Sensitivity Data
The sensitivity of Avanti Polar Lipids, Inc. VDRL Antigen Slide Test Kit was 86.5% for a sample population of 100 documented cases of syphilis. -
iii. Reproducibility Data
Specimens from a blind, coded panel were measured at two independent test sites. Reproducibility was demonstrated with inter-day and intra-day testing. Weakly reactive, reactive and non-reactive specimens were included in the panel. A maximum inter-day and intra-day difference of one doubling dilution was observed when specimens were tested by the same clinician. All reactive specimens gave an end point within two doubling dilutions of the true end point when tested by different clinicians. -
j. Conclusion
The safety and effectiveness of Avanti Polar Lipids VDRL Antigen Slide Test Kit is substantially equivalent to legally marketed VDRL Antigen Slide Test Kits, as demonstrated in the comparison of the performance of Avanti Polar Lipids VDRL Antigen Slide Test Kit to these VDRL Antigen Slide Test Kits.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus, a symbol often associated with healthcare. The emblem features three parallel lines that curve and converge, creating a sense of movement and unity.
Public Health Service
SEP 20 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rowena Shaw Vice President Avanti Polar Lipids, Inc. 700 Industrial Park Drive Alabaster, Alabama 35007
Re: K992124 Trade Name: Avanti Polar Lipids VDRL antigen Slide Test Kit Regulatory Class: II Product Code: GMQ Dated: June 22, 1999 Received: June 23, 1999
Dear Ms. Shaw:
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 (OS) 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.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number (if known):____K992124
Avanti Polar Lipids VDRL Antigen Slide Test Kit Device Name:
Indications For Use:
Avanti's VDRL antigen and Buffered Saline are intended for use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis. The VDRL slide test is a non-treponemal, microflocculation test, that provides both qualitative and semiquantitative results. The test detects the presence of IgM and IgG anticardiolipin antibodies in serum. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sally 7. Selzpak for i Dubois
Division St. Off.
Division of Clinical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).