← Product Code [LIP](/submissions/MI/subpart-d%E2%80%94serological-reagents/LIP) · K050590
# ENZY-WELL SYPHILIS IGG, MODEL 91106 (K050590)
_Diesse Diagnostica Senese S.P.A. · LIP · Aug 10, 2006 · Microbiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIP/K050590
## Device Facts
- **Applicant:** Diesse Diagnostica Senese S.P.A.
- **Product Code:** [LIP](/submissions/MI/subpart-d%E2%80%94serological-reagents/LIP.md)
- **Decision Date:** Aug 10, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3830
- **Device Class:** Class 2
- **Review Panel:** Microbiology
## Indications for Use
For in vitro diagnostic use only. ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum by a manual technique. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum.
## Device Story
ENZY-WELL SYPHILIS IgG is an ELISA-based diagnostic test for qualitative detection of IgG antibodies to Treponema pallidum in human serum. The assay uses microplate wells coated with T. pallidum antigen. Patient samples are incubated in the wells; specific IgG antibodies bind to the antigen. After washing, a peroxidase-labeled anti-human IgG conjugate is added. A substrate is introduced to produce a colorimetric reaction, which is stopped by an acidic solution. The absorbance is measured at 450 nm using a spectrophotometer. The device is intended for use in clinical laboratories by trained personnel. Results are used by clinicians alongside non-treponemal test results to provide serological evidence of syphilis infection, aiding in patient diagnosis and management.
## Clinical Evidence
Clinical performance evaluated using 525 samples across three groups (syphilitic, negative, and other pathologies). Comparison with CAPTIA Syphilis-G showed 100% positive agreement (125/125) and 99.6% negative agreement (299/300). Additional studies at independent labs compared the device against other commercial tests and reference methods (FTA-ABS, TPHA). Analytical specificity was 100% based on 332 samples including various disease states (HCV, HBV, hypergammaglobulinemia, pregnancy). Precision studies (within-run and between-run) demonstrated CVs generally below 15%.
## Technological Characteristics
ELISA-based immunoenzymatic assay. Components: microplate wells coated with T. pallidum antigen, peroxidase-labeled human IgG monoclonal antibody conjugate, substrate, and stop solution. Detection via spectrophotometric absorbance at 450 nm. Manual technique. No specific software algorithm or connectivity described; standard laboratory equipment required for incubation, washing, and absorbance reading.
## Regulatory Identification
Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.
## Predicate Devices
- Trinity Biotech CAPTIA Syphilis-G Elisa Test Kit
## Reference Devices
- FTA-ABS
- TPHA
- VDRL
## Submission Summary (Full Text)
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K050590
Attachment no.5 to the December 9,2005 Letter
AUG 1 0 2006
Page 119
#### Appendix C
510(k) Summary of Safety and Effectiveness
| Name | DIESSE Diagnostica Senese SpA | |
|---------|-------------------------------------------------------------------------------------------|----------------------|
| Address | Via delle Rose 10, 53035 Monteriggioni
SI
Tel. 39-0577-587111
Fax 39-0577-318690 | |
| | Contact Person | Dr. Francesco Cocola |
| | Phone Number | 39-0577-587143 |
| | Fax Number | 39-0577-318379 |
The Following section is included as required by the Safe Medical Device Act (SMDA) 1990. 510(k) Summary of Safety and Effectiveness
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: K050590 Applicant
| Date
Prepared | February 4, 2004 |
|-------------------|--------------------------------------------------------------------------------------------------------|
| Name | DIESSE Diagnostica Senese SpA |
| Address | Via delle Rose 10, 53035 Monteriggioni SI, Italy
Tel. 011-39-0577- 587111
Fax 011-39-0577-318690 |
| Contact
Person | Dr. Francesco Cocola |
| Phone
Number | 39-0577-587143 |
| Fax Number | 39-0577-318379 |
Device information
| Trade Name | ENZY-WELL SYPHILIS IgG |
|------------------------|-------------------------------------------------------|
| Classification
Name | Enzyme linked immunosorbent assay, Treponema pallidum |
| Equivalent Device | |
Equivalent Device
Trinity Biotech CAPTIA Syphilis-G Elisa Test Kit
Device Description
ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the qualitative detection of IgG antibodies to Treponema pallidum in human serum/ plasma. The test may be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum.
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# Principle of the assay
The ENZY-WELL SYPHILIS IgG test is based on the ELISA technique (Enzyme-linked immunosorbent assay). Diluted patient sample is incubated in microplate wells coated with T. pallidum. During this incubation specific immunoglobulins, if present, bind to the antigen on the well. After washing, to eliminate unbound proteins, a second incubation is performed with the conjugate, composed of human IgG monoclonal antibodies labeled with peroxidase. After washing to remove unbound conjugate from the wells, the substrate is added, which will react to produce color in the presence of the peroxidase. An acidic solution is added to stop the reaction and the absorbance of the developed color is read at 450 nm
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# Performance Characteristic
Comparison studies, precision studies, interference and specificity studies, expected values were performed. Performance was evaluated at Azienda Ospedaliera Umberto I (Ancona).
#### CLINICAL SAMPLE CORRELATION
A total of 525 samples were collected and tested to study the performance of the ENZY-WELL SYPHILIS laG kit.
FIRST group: 125 serum samples from both pediatric and adult male and female patients with syphilis.
SECOND group: 300 negative sera; 150 of these serum samples came from clinical sources and/or from a blood donor facility and 150 samples from normal donors.
THIRD group: 100 samples from subjects with no known history or serological evidence of syphilis and suspected for different kinds of infective or clinical pathology.
In the first group of the 125 syphilitic sera there was no disagreement between two comparative testing methods; therefore the reference method FTA-ABS was not used. In the second group of the 300 syphilis-negative sera there was one sample not in agreement. It was equivocal with the ENZY-WELL SYPHILIS IgG test and negative with the CAPTIA Syphilis - G test. The confirmatory FTA-ABS test was negative (it was also negative with TPHA and VDRL test).
#### Table n°1
Results obtained with ENZYWELL vs. Captia Syphills-G, testing 127(First Group ) Syphilitic sera:
| | | CAPTIA Syphilis - G | | |
|----------------------------------|-----------|---------------------|-----------|----------|
| | | Negative | Equivocal | Positive |
| ENZY-
WEL
SYPHI
LIS IgG | Negative | 0 | 0 | 0 |
| | Equivocal | 0 | 0 | 0 |
| | Positive | 0 | 0 | 125 |
Results:
Percent agreement positive = 100 %. 95% CI: 100% and Specificity | |
|--------------|--------|-----|-----|-----------------------------------------|--------------|
| FTA | Pos | Eqv | Neg | % | 95 % C.I. |
| Reactive | 29 | 3 | 1 | 96.7 | 90.2 to 100 |
| Non-Reactive | 5 | 1 | 75 | 88.4 | 90.3 to 99.0 |
| | | | | 94.5 | 90.3 to 98.8 |
Lab B
Lab C
| | EIA | | | % Agreement (Pos.
or Neg.) | |
|-----------|-----|-----|-----|-------------------------------|--------------|
| EnzyWELI | Pos | Eqv | Neg | % | 95 % C.I. |
| Positive | 7 | 2 | 2 | 77.8 | 50.6 to 100 |
| Equivocal | 0 | 1 | 0 | | |
| Negative | 2 | 2 | 257 | 99.2 | 98.2 to 100 |
| | | | | 98.5 | 97.1 to 99.9 |
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23
8
6
10
370
801
101
୧୫
6.3
1.1
8.6
10.0
Excluding equivocal results, a total of 10 samples gave discordant results. When these samples were tested by a third commercially available test, the referee test agreed with the Diesse test for 8 of the 10 discordant samples tested.
# PRECISION
All samples (Cut-Off Control, Positive Control and Negative Control) were tested in triplicate in two separate runs on three different days. CV lower than 15% are accepted. Within run Precision
| DAY 1 | Replicates | RUN 1 | | | RUN 2 | | |
|---------------|------------|-------|------|------|-------|------|------|
| SAMPLES | 3 | O.D. | S.D. | CV% | O.D. | S.D. | CV% |
| CutOff | 3 | 353 | 22 | 6.2 | 324 | 23 | 7.1 |
| Pos. control. | 3 | 1171 | 20 | 1.7 | 1091 | 91 | 8.4 |
| Neg. Control | 3 | 49 | 1 | 2.3 | 49 | 2 | 3.5 |
| Pos serum 1 | 3 | 1687 | 28 | 1.7 | 1524 | 137 | 9.0 |
| Pos serum 2 | 3 | 2141 | 89 | 4.1 | 2184 | 50 | 2.3 |
| Pos serum 3 | 3 | 383 | 13 | 3.3 | 329 | 32 | 9.8 |
| Pos serum 4 | 3 | 838 | 18 | 2.1 | 766 | 59 | 7.7 |
| Neg serum1 | 3 | 75 | 3 | 4.1 | 67 | 5 | 7.0 |
| Neg serum2 | 3 | 86 | 11 | 12.4 | 80 | 3 | 4.3 |
| DAY 2 | Replicates | RUN 1 | | | RUN 2 | | |
| SAMPLES | 3 | O.D. | S.D. | CV% | O.D. | S.D. | CV% |
| CutOff | 3 | 386 | 27 | 6.9 | 314 | 14 | 4.5 |
| Pos control. | 3 | 1235 | 83 | 6.7 | 1233 | 60 | 4.9 |
| Neg. control | 3 | 37 | 1 | 2.7 | 35 | 0 | 0.0 |
| Pos serum 1 | 3 | 1787 | 82 | 4.6 | 1706 | 43 | 2.5 |
| Pos serum 2 | 3 | 2408 | 59 | 2.4 | 2351 | 94 | 4.0 |
| Pos serum 3 | 3 | 360 | 21 | 5.7 | 322 | 24 | 7.4 |
| Pos serum 4 | 3 | 879 | 84 | 9.6 | 775 | 57 | 7.4 |
| Neg serum1 | 3 | 68 | 9 | 12.7 | 52 | 3 | 5.8 |
| Neg serum2 | 3 | 80 | 4 | 5.4 | 76 | 21 | 27.4 |
| DAY 3 | Replicates | RUN 1 | | | RUN 2 | | |
| SAMPLES | 3 | O.D. | S.D. | CV% | O.D. | S.D. | CV% |
| Cut-Off | 3 | 342 | 9 | 2.7 | 339 | 14 | 4.0 |
| Pos Control. | 3 | 1218 | 26 | 2.1 | 1204 | 83 | 6.9 |
| Neg Control | 3 | 34 | 4 | 11.2 | 34 | 1 | 3.4 |
| Pos serum 1 | 3 | 1613 | 57 | 3.6 | 1633 | 40 | 2.4 |
| Pos serum 2 | 3 | 1958 | 228 | 11.7 | 2093 | 176 | 8.4 |
5.1 3 365 19 Pos serum 3 3 769 48 6.2 Pos serum 4 5.7 3 Neg serum 1 3 61 7.2 5 Neg serum 2 દર્ભ 3
Between run Precision
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| | INDEX | | |
|------------------|-------------|-----|------|
| SAMPLE | O.D AVERAGE | SD | CV% |
| CUTOFF | 343 | 18 | 5.2 |
| Pos. Control. | 1192 | 61 | 5.1 |
| Neg. Control | 40 | 1 | 3.9 |
| Positive serum 1 | 1658 | 65 | 4.0 |
| Positive serum 2 | 2189 | 116 | 5.5 |
| Positive serum 3 | 355 | 22 | 6.3 |
| Positive serum 4 | 805 | 46 | 5.7 |
| Negative serum 1 | 71 | 5 | 7.5 |
| Negative serum 2 | 76 | 8 | 10.9 |
In addition, the kit positive and negative controls, plus six additional samples, including 2 negatives and four positives, were assayed in triplicate, in three different runs, at three independent laboratories, using automated analyzers.
### Within Run Precision
### Lab·A
| | Run 1 | | | Run 2 | | | Run 3 | | |
|-----|-------|------|------|-------|------|------|-------|------|------|
| ID | O.D. | S.D. | CV% | O.D. | S.D. | CV% | O.D. | S.D. | CV% |
| PC | 1870 | 211 | 11.3 | 2108 | 227 | 10.8 | 2358 | 114 | 4.8 |
| NC5 | 2 | NA | NA | 0 | 0 | NA | 0 | 0 | NA |
| A | 52 | 20 | NA | 0 | 0 | NA | 0 | 0 | NA |
| B | 55 | 6 | NA | 0 | 0 | NA | 0 | 0 | NA |
| C | 617 | 44 | 7.2 | 398 | 61 | 15.2 | 501 | 48 | 9.5 |
| D | 603 | 105 | 17.4 | 463 | 101 | 21.8 | 543 | 60 | 11.0 |
| E | 1013 | 38 | 3.7 | 1004 | 56 | 5.5 | 1222 | 67 | 5.5 |
| F | 1010 | 100 | 9.9 | 890 | 53 | 5.9 | 1224 | 74 | 6.0 |
Lab B
| Run 1 | | | Run 2 | | | Run 3 | | | |
|-------|------|------|-------|------|------|-------|------|------|-----|
| ID | O.D. | S.D. | CV% | O.D. | S.D. | CV% | O.D. | S.D. | CV% |
| PC | 1802 | 32 | 1.8 | 1740 | 29 | 1.6 | 1825 | 17 | 0.9 |
| NC | 142 | 104 | NA | 96 | 61 | NA | 136 | 92 | NA |
| A | 138 | 17 | NA | 94 | 28 | NA | 136 | 55 | NA |
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| B | 96 | 47 | NA | 67 | 37 | NA | 86 | 73 | NA |
|---|------|-----|------|------|----|-----|------|----|-----|
| C | 637 | 81 | 12.7 | 597 | 58 | 9.7 | 614 | 51 | 8.4 |
| D | 782 | 39 | 5.0 | 691 | 17 | 2.5 | 770 | 48 | 6.3 |
| E | 1202 | 101 | 8.4 | 1050 | 60 | 5.8 | 1177 | 77 | 6.6 |
| F | 1010 | 89 | 8.8 | 995 | 94 | 9.5 | 981 | 69 | 7.0 |
Lab C
. :
.
| | Run 1 | | | Run 2 | | | Run 3 | | | |
|--|-------|------|------|-------|------|------|-------|------|------|-----|
| | ID | O.D. | S.D. | CV% | O.D. | S.D. | CV% | O.D. | S.D. | CV% |
| | PC | 2766 | 30 | 1.1 | 2747 | 116 | 4.3 | 2850 | 49 | 1.7 |
| | NC | 0 | 30 | NA | 0 | 0 | NA | 2 | 0 | NA |
| | A | 13 | 0 | NA | 14 | 9 | NA | 14 | 8 | NA |
| | B | 57 | 10 | NA | 59 | 6 | NA | 54 | 2 | NA |
| | C | 824 | 10 | 1.3 | 887 | 70 | 7.9 | 823 | 74 | 9.1 |
| | D | 909 | 38 | 4.1 | 942 | 19 | 2.0 | 937 | 28 | 3.0 |
| | E | 1502 | 70 | 4.7 | 1489 | 42 | 2.8 | 1567 | 41 | 2.6 |
| | F | 1469 | 28 | 1.9 | 1659 | 63 | 3.8 | 1470 | 65 | 4.4 |
# Between Run Precision
| | Lab A | | | Lab B | | | Lab C | | |
|-------|-----------|-------------------------------------------------------|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----|
| | | ID O.D. S.D. CV% O.D. S.D. CV% O.D. S.D. CV% | | | | | | | |
| | | PC 2112 271 12.8 1789 45 | | | | 2.5 | 2788 83 | | 3.0 |
| INC 2 | | ിച്ച | INA | 125 | 85 | INA | र | 11 | INA |
| রে | 17 | 28 | INA | 123 | 43 | INA | 14 | ರಿ | INA |
| B | 18 | 28 | NA | 83 | 055 | INA | 57 | 17 | INA |
| ಲ | રિવર્સ | 106 | 21.0 | 616 | 61 | ರಿ ಕಿ | 845 | 68 | 8.1 |
| D | 536 | 102 | 19.0 | 748 | 56 | 7.5 | ರಿನ ಕಿರಿ ನಿರ್ವಾರಿ ನಿರ್ವಹಿಸಿದ ಮಾರ್ಥಿಕ ಸಿರ್ವಹಿಸಿದ ಮಾರ್ಥಿಕ ಸಿರ್ವಹಿಸಿದ ಮಾರ್ಥಿಕ ಸಾಮಾನ್ಯ ಸಾಮಾನ್ಯವಾಗಿ ಮಾಡಿ ಮಾಡಿದ್ದಾರೆ. ಇದನ್ನು ಕಾರ್ಯಕ್ಕೆ ಮಾರ್ಗ್ ಅವರ ಮಾಡಿ ಮಾಡಿದ್ದಾರೆ. ಇದನ್ನು ಕಾರ್ಯಕ್ಕೆ | 043 | 4.6 |
| | | | | | | | | | |
| يلا | 1080 119 | | 11.0 | 1143 103 | | 9.0 | 1520 51 | | 3.3 |
| | | | | | | | | | |
| F | 1041 164 | | 15.7 | രിക്കും. അവലംബം പ്രശസ്ത പ്രവരിച്ചു. അവലംബം അതിനും പ്രവരിച്ചു. അവലംബം അതിനും പ്രവരിച്ചു. അവലംബം അതിനും അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അവലംബം അ | 078 | 17.9 | 1533 113 | | 7.4 |
Interlaboratory Precision
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| ID | O.D. | S.D. | CV% |
|----|------|------|-----|
| PC | 2230 | 510 | 23 |
| NC | 43 | 71 | NA |
| A | 51 | 62 | NA |
| B | 53 | 33 | NA |
| C | 656 | 173 | 26 |
| D | 738 | 197 | 27 |
| E | 1248 | 238 | 19 |
| F | 1190 | 298 | 25 |
# CROSSREACTIVITY & INTERFERENCE STUDIES
In order to demonstrate Analitycal Specificity and Interferences an internal experimentation was performed using a total of 332 sera with known disease. Experimentation was performed in two times. The first time the following 130 sera, collected from seroteque, were tested. 73 sera from adults females, 57 from adult males. All these were characterized as follows:
| CATEGORY OF SPECIMENS | n |
|------------------------|----|
| ALT | 20 |
| HCV Positives | 21 |
| HCV Ab Reactive | 9 |
| Hypergammaglobulinemia | 19 |
| Pregnant | 50 |
| Total Bilirubine | 2 |
| Lipemic | 2 |
| Mono test (MT) | 8 |
In a second day 202 sera were tested. Sera summarized below:
| CATEGORY OF SPECIMENS | n |
|-----------------------|-----|
| HCV Positives | 46 |
| Pregnant | 110 |
| HBSAg Vaccinated | 30 |
| HBSAg Positives | 15 |
Obtained Results:
{8}------------------------------------------------
Attachment no.5 to the December 9,2005 Letter
| 19.
P | |
|----------|--|
| 11 | |
| CATEGORY OF SPECIMENS | n | ENZY-WELL
SYPHILIS IgG
Reactive |
|------------------------|-----|---------------------------------------|
| HbsAg Vaccinated | 30 | 0 |
| HBsAg Positives | 15 | 0 |
| ALT | 20 | 0 |
| Sera from HBV Vaccines | 11 | 0 |
| HCV Positives | 64 | 1* |
| HCV Ab Reactive | 9 | 0 |
| Hypergammaglobulinemia | 19 | 0 |
| Pregnant | 160 | 0 |
| Total Bilirubine | 2 | 0 |
| Lipemic | 2 | 0 |
| Total Specimen | 332 | |
Note: Confirmed positive with TPHA
Conclusion:
Only one sample that results reactive when tested with
ENZY- WELL Syphilis IgG was confirmed to be positive with TPHA (Confirmatory test)
Analytical specificity= 100%
No interferences are shown.
{9}------------------------------------------------
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
#### Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Raul Alvarez Consultant Diesse Inc. 1690 W. 38 Place, Unit B 1 Hialeah, Florida 33012
# AUG 1 0 2006
k050590 Re: Trade/Device Name: ENZY-WELL Syphilis IgG Regulation Number: 21 CFR § 866.3830 Regulation Name: Treponema pallidum treponemal test reagent Regulatory Class: II Product Code: LIP Dated: May 30, 2006 Received: June 5, 2006
Dear Mr. Alvarez:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as begin marketing your device as described in your Section 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.
{10}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Sally, anton
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
# Indications for Use
510(k) Number : K050590
Device Name: ENZY-WELL Syphilis IgG
Indications For Use:
- For in vitro diagnostic use only. 1.
- ENZY-WELL SYPHILIS IgG is an immunoenzymatic method for the 2. qualitative detection of IgG antibodies to Treponema pallidum in human serum by a manual technique.
- The test may be used in conjunction with non-treponemal testing to provide 3. serological evidence of infection with T. pallidum.
Prescription Use __________ AND/OR x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddi L. Poole
Division Sign-Off
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
310(k) KD50590
---
**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIP/K050590](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIP/K050590)
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