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K Number
K093784
Device Name
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
2010-07-16

(219 days)

Product Code
OPMLFZLGDMXJMYF
Regulation Number
866.3510
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV 1 and HSV 2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The test is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.
Device Description
The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is a multiplex immunoassav intended for the simultaneous qualitative detection and differentiation of specific human IgG class antibodies to Toxoplasma gondii, Rubella, Cytomegalovirus (CMV), Herpes Simplex 1 (HSV-1) and Herpes Simplex 2 (HSV-2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to infection with Toxoplasma gondii, Rubella, CMV, HSV 1 and HSV 2 and in the determination of immune status of individuals including pregnant women. The test system is comprised of the AtheNA Multi-Lyte test kit, software and the Luminex Corp instrument. The AtheNA Multi-Lyte ToRCH IgG Plus Test System provides the following components: Reactive Reagents: All reactive reagents contain sodium azide as a preservative at a concentration of 0.1% (w/v). 1. Multiplexed bead suspension 1. Ready to use, 5.5 mL bottle. The suspension contains separate distinguishable 5.6 micron polystyrene beads that are conjugated with: . Toxo grade 2 antigen . Rubella K2S grade antigen CMV grade 2 . HSV-1 type-specific recombinant gG-1 protein antigen . HSV-2 gG-2 type-specific recombinant gG-2 protein antigen The bead mix also contains one bead set designed to detect non-specific antibodies in the patient sample (if present) and four separate bead sets used for assay calibration. 2. Conjugate: Phycoerythrin conjugated goat anti-human IgG (y chain specific). Ready to use, 15 mL amber bottle. 3. Human positive serum control 1. One, 0.2 mL vial. 4. Human positive serum control 2. One, 0.2 mL vial. 5. Human negative serum control. One, 0.2 mL vial. 6. SAVe Diluent®. One 50 mL bottle containing phosphate-buffered-saline. Ready to use. NOTE, the sample diluent will change color in the presence of serum. 7. Wash Buffer Concentrate: dilute 1 part concentrate + 9 parts deionized or distilled water. One bottle containing 10 X concentrate of phosphate buffered saline. Non-Reactive Reagents 1. One, 96-well filtration plate for rinsing the microspheres 2. Data Labels: One label is adhered to the inside lid of the kit box and a second label is inside the kit box. 3. Package Insert providing instructions for use 4. Calibration CD: a compact disc that includes all lot-specific kit calibration values required for specimen analysis and assay quality control
More Information

510(k)891781, 510(k)891783, 510(k)924096, 510(k)000238

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No
The summary describes a multiplex immunoassay system that uses beads conjugated with antigens and a Luminex instrument for detection. The analysis and performance studies focus on agreement with predicate devices and reference panels, precision, and reproducibility, which are standard for immunoassay validation. There is no mention of AI, ML, or any computational methods beyond standard data processing for calculating results and statistical analysis.

No
This device is an in vitro diagnostic (IVD) test system designed to detect specific antibodies, aiding in the diagnosis of past or present infections and assessment of immune status. It does not provide any treatment or therapy.

Yes

Explanation: The device is intended for the qualitative detection of specific human IgG class antibodies to various pathogens. This information is used as an aid in diagnosing or assessing the serological status of individuals for these infections, which falls under the definition of a diagnostic device.

No

The device description explicitly states that the system is comprised of a test kit, software, and a Luminex Corp instrument. The test kit includes various reactive and non-reactive reagents and a filtration plate, which are physical components. Therefore, it is not a software-only medical device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states the device is for the "qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and HSV 1 & 2 in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a person's health status (presence of antibodies indicating exposure or immunity).
  • Device Description: The description details a "multiplex immunoassay intended for the simultaneous qualitative detection and differentiation of specific human IgG class antibodies... in human serum." This further confirms the in vitro nature of the testing.
  • Components: The listed components are typical of an immunoassay kit used for laboratory testing of biological samples.
  • Performance Studies: The performance studies involve testing human serum samples and comparing results to predicate devices and reference panels, which is standard practice for validating IVDs.

The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device clearly fits that definition.

N/A

Intended Use / Indications for Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV 1 and HSV 2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2.

The test is not intended for use in screening blood or plasma donors.

The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.

Product codes (comma separated list FDA assigned to the subject device)

LGD, LFX, LFZ, MXJ, MYF, OPM

Device Description

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is a multiplex immunoassav intended for the simultaneous qualitative detection and differentiation of specific human IgG class antibodies to Toxoplasma gondii, Rubella, Cytomegalovirus (CMV), Herpes Simplex 1 (HSV-1) and Herpes Simplex 2 (HSV-2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to infection with Toxoplasma gondii, Rubella, CMV, HSV 1 and HSV 2 and in the determination of immune status of individuals including pregnant women. The test system is comprised of the AtheNA Multi-Lyte test kit, software and the Luminex Corp instrument.

The AtheNA Multi-Lyte ToRCH IgG Plus Test System provides the following components:

Reactive Reagents:

All reactive reagents contain sodium azide as a preservative at a concentration of 0.1% (w/v).

  1. Multiplexed bead suspension 1. Ready to use, 5.5 mL bottle. The suspension contains separate distinguishable 5.6 micron polystyrene beads that are conjugated with:
    . Toxo grade 2 antigen
    . Rubella K2S grade antigen
    . CMV grade 2
    . HSV-1 type-specific recombinant gG-1 protein antigen
    . HSV-2 gG-2 type-specific recombinant gG-2 protein antigen

The bead mix also contains one bead set designed to detect non-specific antibodies in the patient sample (if present) and four separate bead sets used for assay calibration.

  1. Conjugate: Phycoerythrin conjugated goat anti-human IgG (y chain specific). Ready to use, 15 mL amber bottle.
  2. Human positive serum control 1. One, 0.2 mL vial.
  3. Human positive serum control 2. One, 0.2 mL vial.
  4. Human negative serum control. One, 0.2 mL vial.
  5. SAVe Diluent®. One 50 mL bottle containing phosphate-buffered-saline. Ready to use. NOTE, the sample diluent will change color in the presence of serum.
  6. Wash Buffer Concentrate: dilute 1 part concentrate + 9 parts deionized or distilled water. One bottle containing 10 X concentrate of phosphate buffered saline.

Non-Reactive Reagents

  1. One, 96-well filtration plate for rinsing the microspheres
  2. Data Labels: One label is adhered to the inside lid of the kit box and a second label is inside the kit box.
  3. Package Insert providing instructions for use
  4. Calibration CD: a compact disc that includes all lot-specific kit calibration values required for specimen analysis and assay quality control

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

The test is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  • Clinical Performance:

    • Sample Size: 851 unselected samples from various serum vendors; 300 tested at a Mid-Atlantic hospital laboratory; 351 tested at a Northeast hospital laboratory; 200 samples from Expectant Mothers tested at the manufacturing site's laboratory.
    • Study Type: Comparative testing against predicate assays for intended use populations. Additional clinical performance assessed in special populations (HSV-1 and HSV-2 low prevalence, Rubella relative specificity). Performance with International Standards and CDC Reference Panels.
    • Key Results:
      • Observed Prevalence in Individuals Undergoing TORCH Antibody Assessment:
        • Toxoplasma: Overall Positive/Total 160/651 (24.6% Prevalence)
        • Rubella: Overall Positive/Total 582/651 (89.4% Prevalence)
        • CMV: Overall Positive/Total 459/651 (71.0% Prevalence)
      • Observed Prevalence in Pregnant Women:
        • Toxoplasma: Overall 29/200 (14.50% Prevalence)
        • Rubella: Overall 194/200 (97.90% Prevalence)
        • CMV: Overall 151/200 (75.50% Prevalence)
        • HSV 1: Overall 160/200 (80.00% Prevalence)
        • HSV 2: Overall 75/200 (37.50% Prevalence)
      • Observed Prevalence in Sexually Active Adults (HSV 1 and HSV 2):
        • HSV 1: Overall 450/596 (75.5% Prevalence)
        • HSV 2: Overall 153/594 (25.8% Prevalence)

  • Performance in Prospectively Collected Intended Use Populations:

    • Sample Size: 651 individuals.
    • Toxoplasma: PPA 99.3% (136/137), 95% CI 96.0% - 100%; NPA 95.7% (450/514), 95% CI 98.0% - 99.9%.
    • Rubella: PPA 98.5% (533/541), 95% CI 97.1% - 99.4%; NPA *87% (60/69), 95% CI 76.7% - 93.9%.
    • CMV: PPA 99.6% (450/452), 95% CI 98.4% - 100%; NPA 91.3% (181/197), 95% CI 87.2% - 95.3%.

  • HSV1 and HSV2 Performance in Sexually Active Adults:

    • Sample Size: 596/651 individuals.
    • HSV 1: Sensitivity 98.6% (418/424), 95% CI 97.0% - 99.5%; Specificity 94.6% (163/172), 95% CI 90.3% - 97.6%.
    • HSV 2: Sensitivity 96.9% (127/131), 95% CI 92.4% - 98.8%; Specificity 93.5% (433/463), 95% CI 90.9% - 95.6%.

  • Performance in Pregnant Women Population:

    • Sample Size: 200 samples.
    • Toxoplasma: NPA 100.0% (22/22), 95% CI 87.3% - 100%. (Table data is incomplete for Sensitivity/PPA/NPA across all analytes for this section.)
    • Rubella: PPA 99.0% (194/196), 95% CI 96.4% - 99.9%; 100.0% (4/4) between 47.3% - 100%.
    • CMV: PPA 98.1% (151/154), 95% CI 94.4% - 99.6%; NPA 100.0% (46/46), 95% CI 93.7% - 100%.
    • HSV 1: PPA 99.3% (137/138), 95% CI 96.1% - 100%; NPA 85.2% (46/54), 95% CI 72.3% - 93.4%.
    • HSV 2: PPA 97.1% (68/70), 95% CI 90.1% - 99.7%; NPA 92.6% (113/122), 95% CI 86.5% - 96.6%.

  • Agreement with CDC Panel:

    • Sample Size: Varies per panel (Toxo 100, Rubella 100, CMV 100, HSV 100).
    • Toxoplasma: PPA 100.0% (70/70), 95% CI 95.8% - 100.0%; NPA 100.0% (30/30), 95% CI 90.5% - 100.0%.
    • Rubella: PPA 100.0% (80/80), 95% CI 96.3% - 100.0%; NPA 100.0% (20/20), 95% CI 86.1% - 100.0%.
    • CMV: PPA 100.0% (52/52), 95% CI 94.4% - 100.0%; NPA 95.8% (46/48), 95% CI 90.2% - 100.0%.
    • HSV 1: PPA 100.0% (50/50), 95% CI 94.2% - 100.0%; NPA 100.0% (50/50), 95% CI 94.2% - 100.0%.
    • HSV 2: PPA 100.0% (48/48), 95% CI 94.0% - 100.0%; NPA 98.1% (51/52), 95% CI 94.3% - 100.0%.

  • HSV 1 & 2 Performance in a Low Prevalence Population:

    • Sample Size: 67 subjects.
    • HSV-1 Reactivity: Agreed with 85.7% (6/7) of immunoblot positives and 98.3% (59/60) of immunoblot negatives.
    • HSV-2 Reactivity: Agreed with 100% (0/0) of immunoblot positives and 100% (67/67) of immunoblot negatives.
    • HSV 1: PPA 100.0% (8/8), 95% CI 68.8% - 100%; NPA 96.6% (56/58), 95% CI 88.1% - 99.6%.
    • HSV 2: PPA 100.0% (3/3), 95% CI 36.8% - 100%; NPA 98.4% (62/63), 95% CI 91.5% - 100%.

  • Rubella Retrospective Negative Sample Study:

    • Sample Size: 100 samples previously tested negative.
    • Rubella Reactivity: Agreed with 100% (0/0) of ELISA positives and 100% (100/100) of ELISA negatives.
    • NPA 100.0% (100/100), 95% CI 97.1% - 100%.

  • Clinical performance with International Standards:

    • Rubella Traceability to WHO Standard: At 10.63 IU/mL, Lot 1 mean recovery 96%, Lot 2 mean recovery 102%.
    • Rubella Low Titer Standard (21 IU/mL): % Recovery ranged from 93% to 111% across technicians for neat and 1:2 diluted samples.

  • Precision and Reproducibility:

    • Study Type: Internal evaluation and two external clinical sites. Six samples (two negative, two high positive, two near cut-off) per analyte. Each sample aliquoted twice and run in triplicate daily for three days at each site.
    • Key Results: Tables provided show Within-Run, Between-Day, Between-Run, Between-Site variability (SD and %CV) and Total variability for Toxoplasma, Rubella, CMV, HSV 1, and HSV 2 IgG for various sample levels.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • Sensitivity/PPA (Positive Percent Agreement):

    • Toxoplasma: 99.3% (136/137) in intended use population.
    • Rubella: 98.5% (533/541) in intended use population.
    • CMV: 99.6% (450/452) in intended use population.
    • HSV 1: 98.6% (418/424) in sexually active adults.
    • HSV 2: 96.9% (127/131) in sexually active adults.
    • Pregnant Women: Toxoplasma 100.0% (22/22) for positive, Rubella 99.0% (194/196), CMV 98.1% (151/154), HSV 1 99.3% (137/138), HSV 2 97.1% (68/70).
    • CDC Panel: Toxoplasma 100.0% (70/70), Rubella 100.0% (80/80), CMV 100.0% (52/52), HSV 1 100.0% (50/50), HSV 2 100.0% (48/48).
    • Low Prevalence Population: HSV 1 100.0% (8/8), HSV 2 100.0% (3/3).

  • Specificity/NPA (Negative Percent Agreement):

    • Toxoplasma: 95.7% (450/514) in intended use population.
    • Rubella: 87% (60/69) in intended use population.
    • CMV: 91.3% (181/197) in intended use population.
    • HSV 1: 94.6% (163/172) in sexually active adults.
    • HSV 2: 93.5% (433/463) in sexually active adults.
    • Pregnant Women: Rubella 100.0% (4/4), CMV 100.0% (46/46), HSV 1 85.2% (46/54), HSV 2 92.6% (113/122).
    • CDC Panel: Toxoplasma 100.0% (30/30), Rubella 100.0% (20/20), CMV 95.8% (46/48), HSV 1 100.0% (50/50), HSV 2 98.1% (51/52).
    • Low Prevalence Population: HSV 1 96.6% (56/58), HSV 2 98.4% (62/63).
    • Rubella Retrospective Negative Sample Study: 100.0% (100/100).

  • PPV (Positive Predictive Value) (Hypothetical for HSV in Sexually Active Adults and Expectant Mothers):

    • Sexually Active Adults HSV-1: 94.8% at 50% prevalence down to 49.0% at 5.0% prevalence.
    • Sexually Active Adults HSV-2: 93.7% at 50% prevalence down to 44.0% at 5.0% prevalence.
    • Expectant Mothers HSV-1: 87.0% at 50% prevalence down to 26.1% at 5.0% prevalence.
    • Expectant Mothers HSV-2: 92.9% at 50% prevalence down to 40.8% at 5.0% prevalence.

  • NPV (Negative Predictive Value) (Hypothetical for HSV in Sexually Active Adults and Expectant Mothers):

    • Sexually Active Adults HSV-1: 98.5% at 50% prevalence up to 99.9% at 5.0% prevalence.
    • Sexually Active Adults HSV-2: 96.8% at 50% prevalence up to 99.8% at 5.0% prevalence.
    • Expectant Mothers HSV-1: 99.2% at 50% prevalence up to 100.0% at 5.0% prevalence.
    • Expectant Mothers HSV-2: 97.0% at 50% prevalence up to 99.8% at 5.0% prevalence.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

510(k)891781, 510(k)891783, 510(k)924096, 510(k)000238

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 866.3510 Rubella virus serological reagents.

(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.

0

JUL 1 6 2010

Zeus Scientific Inc. 510K Summary:

AtheNA Multi-Lyte® ToRCH IgG Plus Test System

Administrative Information

    1. 510(k): number: K093784
    1. Submission Purpose: Intent to market referenced device for the simultaneous qualitative detection and differentiation of specific human IgG class antibodies to Toxoplasma gondii (Toxo), Rubella, Cytomegalovirus (CMV) and Herpes Simplex 1 (HSV-1) and Herpes Simplex 2 (HSV-2).
    1. Measurand: Toxoplasma, Rubella, CMV, HSV 1 and HSV 2 IgG antibodies.
    1. Type of Test: Multiplex microparticle immunoassay.
  • Applicant: Zeus Scientific, Inc. (Zeus), PO Box 38, Raritan, NJ 08869 (908)526-3744 5.
    1. Proprietary Name: AtheNA Multi-Lyte® ToRCH IgG Plus Test System.
    1. Established name: Toxoplasma, Rubella, Cytomegalovirus, Herpes Simplex 1 and Herpes Simplex 2 serological reagents

Regulatory Information

Toxo

Device Classification: Enzyme Linked Immunoabsorbent Assay Regulation Description: Toxoplasma gondii serological reagents Class: Class 2 Product Code: LGD Panel: Microbiology Regulation Number: 866.3780

Rubella

Device Classification: Enzyme Linked Immunoabsorbent Assay Regulation Description: Rubella virus serological reagents Class: Class 2 Product Code: LFX Panel: Microbiology Regulation Number: 866.3510

CMV

Device Classification: Enzyme Linked Immunoabsorbent Assay Regulation Description: Cytomegalovirus serological reagents Class: Class 2 Product Code: LFZ Panel: Microbiology Regulation Number: 866.3175

HSV-1

1

Device Classification: Enzyme Linked Immunoabsorbent Assay Regulation Description: Herpes Simplex virus serological reagents Class: Class 2 Product Code: MXJ Panel: Microbiology Regulation Number: 866.3305

HSV-2

Device Classification: Enzyme Linked Immunoabsorbent Assay Regulation Description: Herpes Simplex 2 serological reagents Class: Class 2 Product Code: MYF Panel: Microbiology Regulation Number: 866.3305

Intended Use

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV 1 and HSV 2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2.

The test is not intended for use in screening blood or plasma donors.

The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.

Device Description

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is a multiplex immunoassav intended for the simultaneous qualitative detection and differentiation of specific human IgG class antibodies to Toxoplasma gondii, Rubella, Cytomegalovirus (CMV), Herpes Simplex 1 (HSV-1) and Herpes Simplex 2 (HSV-2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to infection with Toxoplasma gondii, Rubella, CMV, HSV 1 and HSV 2 and in the determination of immune status of individuals including pregnant women. The test system is comprised of the AtheNA Multi-Lyte test kit, software and the Luminex Corp instrument.

The AtheNA Multi-Lyte ToRCH IgG Plus Test System provides the following components:

Reactive Reagents:

All reactive reagents contain sodium azide as a preservative at a concentration of 0.1% (w/v).

    1. Multiplexed bead suspension 1. Ready to use, 5.5 mL bottle. The suspension contains separate distinguishable 5.6 micron polystyrene beads that are conjugated with:
    • . Toxo grade 2 antigen

2

  • . Rubella K2S grade antigen
  • CMV grade 2
  • . HSV-1 type-specific recombinant gG-1 protein antigen
  • . HSV-2 gG-2 type-specific recombinant gG-2 protein antigen

The bead mix also contains one bead set designed to detect non-specific antibodies in the patient sample (if present) and four separate bead sets used for assay calibration.

    1. Conjugate: Phycoerythrin conjugated goat anti-human IgG (y chain specific). Ready to use, 15 mL amber bottle.
    1. Human positive serum control 1. One, 0.2 mL vial.
    1. Human positive serum control 2. One, 0.2 mL vial.
    1. Human negative serum control. One, 0.2 mL vial.
    1. SAVe Diluent®. One 50 mL bottle containing phosphate-buffered-saline. Ready to use. NOTE, the sample diluent will change color in the presence of serum.
    1. Wash Buffer Concentrate: dilute 1 part concentrate + 9 parts deionized or distilled water. One bottle containing 10 X concentrate of phosphate buffered saline.

Non-Reactive Reagents

    1. One, 96-well filtration plate for rinsing the microspheres
    1. Data Labels: One label is adhered to the inside lid of the kit box and a second label is inside the kit box.
    1. Package Insert providing instructions for use
    1. Calibration CD: a compact disc that includes all lot-specific kit calibration values required for specimen analysis and assay quality control

Substantial Equivalence

Examination of enclosed data indicates that the Zeus Scientific, Inc AtheNA Multi-Lyte ToRCH IgG Plus Test System for the simultaneous detection and differentiation of IgG class antibodies to Toxo, Rubella, CMV, HSV-1 and HSV-2 is substantially equivalent to commercially marketed test systems which have been previously cleared by the FDA for in vitro diagnostic use.

The comparator information for both cleared and investigational analytes are listed:

Toxoplasma

    1. Name of Predicate Device: Toxo IgG ELISA Test System
  • Manufacturer of Predicate Device: Zeus Scientific, Inc. 2.
    1. 510(k)891781

Rubella

    1. Name of Predicate Device: Rubella IgG ELISA Test System
    1. Manufacturer of Predicate Device: Zeus Scientific, Inc.
    1. 510(k)891783

CMV

  • Name of Predicate Device: CMV IgG ELISA Test System 1.
    1. Manufacturer of Predicate Device: Zeus Scientific, Inc.

3

    1. 510(k)924096

HSV-I

  • Name of Predicate Device: HerpeSelect 1 and 2 Immunoblot IgG 1.
  • Manufacturer of Predicate Device: Focus Diagnostics 2.
    1. 510(k)000238

HSV-2

  • Name of Predicate Device: HerpeSelect 1 and 2 Immunoblot IgG 1.
    1. Manufacturer of Predicate Device: Focus Diagnostics
    1. 510(k)000238

Test Principle

The Zeus Scientific, Inc. AtheNA Multi-Lyte ToRCH IgG Plus Test System is designed to detect IgG class antibodies in human sera to Toxo, Rubella, CMV, HSV-2. The test procedure involves four incubation steps:

    1. Patient sera are diluted test sera are incubated in a vessel containing a multiplexed mixture of the bead suspension. The multiplexed bead suspension contains a mixture of distinguishable sets of polystyrene microspheres; each set conjugated with Toxoplasma, Rubella. CMV, HSV-1 and HSV-2 antigens. The bead mix also contains one bead set designed to detect nonspecific antibodies in the patient sample (if present) and four separate bead sets used for assay calibration. If present in patient sera, the individual antibodies will bind to the corresponding immobilized antigen bead set. The microspheres are rinsed to remove non-reactive serum proteins.
    1. Phycoerythrin-conjugated goat anti-human lgG is added to the vessel and the plate is incubated. The conjugate will react with IgG antibody immobilized on the beads in step 1. The bead suspension is then analyzed by the AtheNA Multi-Lyte® instrument. The bead set(s) are sorted (identified) and the amount of reporter molecule (PE conjugate) is determined for each bead set. Using the Intra-Well Calibration Technology®, internal calibration bead sets are used to to convert raw fluorescence into outcome (units).

Analytical Specificity Interfering Substances

The effect of potential interfering substances on sample results generated using the AtheNA Multi-Lyte test system was evaluated with the following possible interfering substances based on the guidelines established in CLSI EP7-A2: albumin, bilirubin, cholesterol, hemoglobin, triglycerides and intralipids.

The quantity of analyte in each interfering substance is as follows and is based on CLSI EP7-A2:

Bilirubin: 1mg/dL (low), 15 mg/dL (high)

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4

Albumin: 3.5 g/dL (low), 5 g/dL (high) Cholesterol: 150 mg/dL (low), 250 mg/dL (high) Triglycerides: 150 mg/dL (low), 500 mg/dL (high) Hemoglobin: 20 g/dL (low), 20 g/dL (high) Intralipid: 300 mg/dL (low), 750 mg/dL (high)

Three samples each for Toxo, Rubella, CMV, HSV 1 and 2 IgG were chosen based on their performance on the AtheNA Multi-Lyte test system: positive, borderline and negative. The samples were exposed to the possible interfering substance and tested. All samples showed less than a 20% change in signal with the following exceptions:

Potential Interfering Substance Spikes Exhibiting Change in Signal Greater than 20%
BilirubinAlbuminCholesterolTriglyceridesHemoglobinIntralipid
Analyte/Level of SampleHighLowHighLowHighLowHighLowHighLowHighLow
Toxoplasma Positive