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. For in vitro diagnostic use only.

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. 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

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the ENZY-WELL SYPHILIS IgG device, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Criteria	Reported Device Performance (ENZY-WELL SYPHILIS IgG)
Clinical Performance	Sensitivity	Not explicitly stated as a numerical threshold, but implied to be high based on predicate comparison.	100% agreement positive with CAPTIA Syphilis - G (for syphilitic sera), Clinical Sensitivity with FTA: 96.7% (Lab A).
	Specificity	Not explicitly stated as a numerical threshold, but implied to be high based on predicate comparison.	99.6% agreement negative with CAPTIA Syphilis - G (for negative sera), Analytical Specificity: 100% (Cross-reactivity study). Clinical Specificity with FTA: 88.4% (Lab A).
Precision	Within-run CV%	CV lower than 15%	Generally well within 15%, with a few exceptions (e.g., Neg serum2 on Day 2 Run 2, and some values for C and D in Lab A & B intra-run).
	Between-run CV%	Not explicitly stated as a numerical threshold, but implied to be low for consistency.	Ranges from 2.5% to 21% (for positives) and up to NA for negatives (due to very low O.D.).
	Interlaboratory CV%	Not explicitly stated as a numerical threshold, but implied to be low for consistency.	Ranges from 19% to 27% (for positives), and up to NA for negatives.
Cross-Reactivity	Interference	No interferences	No interferences shown, 100% analytical specificity. One HCV positive sample was reactive but confirmed positive by TPHA.

Study Details

Sample sizes used for the test set and data provenance:
- Clinical Sample Correlation (Primary Study):
  - First group (syphilitic sera): 125 samples (pediatric and adult, male and female patients). Data provenance not explicitly stated (e.g., country), but implied to be clinical. Retrospective/prospective not specified.
  - Second group (negative sera): 300 samples (150 from clinical sources/blood donors, 150 from normal donors). Data provenance not explicitly stated, but implied to be clinical. Retrospective/prospective not specified.
  - Third group (different pathologies): 100 samples (no known history/serological evidence of syphilis, suspected for other infective/clinical pathology). Data provenance not explicitly stated. Retrospective/prospective not specified.
- Clinical Studies (Independent Labs): 387 specimens across two independent clinical laboratories (Lab B and Lab C).
- Cross-Reactivity & Interference Studies: 332 sera with known diseases collected from a "seroteque" (implying retrospective sourcing).
- Precision Studies: Various control and serum samples (number not detailed for each type beyond "3 replicates" for specific samples in each run/day experiment).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document primarily relies on "comparative testing methods" and "confirmatory tests" (FTA-ABS, TPHA, VDRL) rather than direct expert consensus on raw data.
- For the 'First group' of 125 syphilitic sera, it states "no disagreement between two comparative testing methods." This suggests at least two methods or interpretations were used, but not necessarily by human experts on individual cases.
- For discordant results in the negative and pathological groups, confirmatory tests like FTA-ABS, TPHA, and VDRL were used. The interpretation of these confirmatory tests would likely be performed by qualified laboratory personnel, but the number and specific qualifications of such "experts" are not detailed.
Adjudication method for the test set:
- For the primary clinical sample correlation, disputes between the ENZY-WELL SYPHILIS IgG and the predicate device (CAPTIA Syphilis - G) were resolved using confirmatory tests like FTA-ABS, TPHA, and VDRL.
- For the 10 discordant samples in the independent clinical study, a "third commercially available test" (referee test) was used, and it agreed with the Diesse test for 8 out of 10 samples.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this device is an immunoassay (laboratory test kit), not an AI-assisted diagnostic device. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented is for the standalone performance of the ENZY-WELL SYPHILIS IgG immunoassay kit. It measures the qualitative detection of IgG antibodies directly from human serum/plasma. There is no "human-in-the-loop" component in the interpretive function of the device itself, although human laboratory technicians perform the assay.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Status: Ground truth was established based on clinical diagnosis of syphilis ("patients with syphilis") or confirmed negative status ("negative to Syphilis").
- Confirmatory Tests: For validation and adjudication of discordant results, established laboratory confirmatory tests were used:
  - FTA-ABS (Fluorescent Treponemal Antibody Absorption)
  - TPHA (Treponema Pallidum Hemagglutination Assay)
  - VDRL (Venereal Disease Research Laboratory)
The sample size for the training set:
- This is an immunoassay kit, not a machine learning or AI model. Therefore, there isn't a traditional "training set" in the computational sense. The "development" of the assay involves optimizing reagents and conditions using internal samples, but these are not typically referred to as a "training set" in the context of device validation. The provided data focuses on the validation of the finalized kit.
How the ground truth for the training set was established:
- As noted above, there is no explicit "training set" for an AI or machine learning model. The ground truth for the performance evaluation (test set) samples was established based on clinical diagnosis, serological history, and confirmatory laboratory tests (FTA-ABS, TPHA, VDRL).

Summary

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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 MonteriggioniSITel. 39-0577-587111Fax 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

DatePrepared	February 4, 2004
Name	DIESSE Diagnostica Senese SpA
Address	Via delle Rose 10, 53035 Monteriggioni SI, ItalyTel. 011-39-0577- 587111Fax 011-39-0577-318690
ContactPerson	Dr. Francesco Cocola
PhoneNumber	39-0577-587143
Fax Number	39-0577-318379

Device information

Trade Name	ENZY-WELL SYPHILIS IgG
ClassificationName	Enzyme linked immunosorbent assay, Treponema pallidum
Equivalent Device

Equivalent Device

Trinity Biotech CAPTIA Syphilis-G Elisa Test Kit

Device Description

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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-WELSYPHILIS IgG	Negative	0	0	0
	Equivocal	0	0	0
	Positive	0	0	125

Results:

Percent agreement positive = 100 %. 95% CI: 100% <Se <100%

Table n°2

Results obtained testing 300 sera( Second Group): 150 sera from clinical source and 150 sera from normal donor, both groups were negative to Syphilis

	CAPTIA Syphilis -G
	Negative	Equivocal	Positive
ENZY-WELL	Negative	299	0	0
	Equivocal	0	0	0
	Positive	1*	0	0

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The test gave a positive result even after repeat testing. Both the confirmatory tests (FTA-ABS and TPHA) gave negative results.

Percent agreement negative = 99.6 %.

95% Cl: 99%<Sp<100%

In the third group of 100 sera with different pathological diseases, two sera gave equivocal results with both methods, also after repeating the test. The confirmatory test gave a positive result with a titer of 1280; the FTA-ABS test also gave positive results.

The Percent agreement negative of ENZY-WELL SYPHILIS IgG kit in this group is 100%

In addition, clinical studies performed at two independent clinical laboratories with a total of three hundred and eighty-seven specimens, comparing the Diesse Enzy-well Syphilis IgG test with two other commercially available tests.

	Diesse			Clinical Sensitivityand 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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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:

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Attachment no.5 to the December 9,2005 Letter

19.P
11

CATEGORY OF SPECIMENS	n	ENZY-WELLSYPHILIS IgGReactive
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.

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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.

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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

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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

Regulation Number and Section

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
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), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).