(423 days)
Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitative detection of Giardia lamblia ( G. lamblia ) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giardia gastrointestinal infections. As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.
The Trinity Biotech Uni-Gold™ Giardia was designed as a single use, rapid, lateral flow immunoassay test device to detect the presence of Giardia lamblia antigen in unpreserved (fresh & frozen), preserved and media containing human stool specimens.
The Trinity Biotech Uni-Gold™ Giardia test strip (5mm x 60mm) combines a Nitrocellulose Membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.
The Giardia Nitrocellulose Membrane Test Strip - above consist of
- A) Mouse anti-Giardia lamblia antibody is coated onto the Test Line region of the test strip.
- B) Rabbit anti-Goat IgG antibody is coated onto the Control Line region of the Test Strip.
- C) Goat anti- Giardia lamblia antibodies and Goat IgG antibodies are conjugated to red latex particles and dried onto the inert glass fiber (Conjugate Pad) which is inserted into the test strip below the nitrocellulose zone.
When Giardia antigens are present in the sample they combine with the antibody/red latex complex. As the complex migrates it binds to the antibodies in the test region forming a visible pink/red band. (Picture B) This forms the basis for the double antibody sandwich assay. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. This internal control line is to ensure and indicate that the test device is functioning correctly.
The plastic housing device contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes.
The test concept:
Mouse anti-Giardia lamblia is coated onto the test line region of the nitrocellulose zone of the test strip. Rabbit anti- Goat IgG is coated onto the control line region.
Goat anti-Giardia lamblia antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone.
A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Giardia antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Giardia capture antibody. If Giardia antigen is present, the immune complex reacts with the anti-Giardia antibody at the test line on the membrane.
Thus Giardia antigens present in the sample combine with the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band.
Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.
Here's a summary of the acceptance criteria and the study details for the Uni-Gold™ Giardia device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative format (e.g., "Sensitivity must be >90%"). However, based on the studies presented, the implicit acceptance criteria are 100% agreement/sensitivity/specificity in the evaluated studies.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance | Study Type | N (positive/negative) |
|---|---|---|---|---|
| Intra-run Precision/Reproducibility | 100% reproducibility | 100% reproducibility | Internal (initial) | 6 blind panel members (2 Low Pos, 2 High Pos, 2 Neg) |
| 100% reproducibility | Internal (additional) | 12 blind panel members (4 Low Pos, 4 High Pos, 4 Neg) | ||
| Agreement vs. Comparator Device | High percent agreement | Site 1: 100% Pos Agr, 94.1% Neg Agr | Retrospective | 26 Pos, 48 Neg (Uni-Gold negative & Comparator Negative, 3 Uni-Gold positive & Comparator negative) |
| Site 2: 100% Pos Agr, 100% Neg Agr | Retrospective | 51 Pos, 49 Neg | ||
| Site 3: 100% Pos Agr, 83.3% Neg Agr | Retrospective | 54 Pos, 30 Neg (Uni-Gold negative & Comparator Negative, 6 Uni-Gold positive & Comparator negative) | ||
| Sensitivity vs. DFA Microscopy | 100% Sensitivity | 100% (91/91) (95% CI 95-100%) | Retrospective | 91 Pos |
| Specificity vs. DFA Microscopy | 100% Specificity | 100% (150/150) (95% CI 97-100%) | Retrospective | 150 Neg |
| Positive Percent Agreement (PPA) vs. Non-Fluorescent Microscopy (Wheatley's Stain) | 100% PPA | 100% (22/22) | Retrospective | 22 Pos |
| Negative Percent Agreement (NPA) vs. Non-Fluorescent Microscopy (Wheatley's Stain) | 100% NPA | 100% (45/45) | Retrospective | 45 Neg |
| Positive Percent Agreement (PPA) vs. Non-Fluorescent Microscopy (Iron Hematoxylin Stain) | 100% PPA | 100% (60/60) | Retrospective | 60 Pos |
| Negative Percent Agreement (NPA) vs. Non-Fluorescent Microscopy (Iron Hematoxylin Stain) | 100% NPA | 100% (199/199) | Retrospective | 199 Neg |
| Specificity vs. DFA Microscopy (Prospective Study) | 100% Specificity | 100% (378/378) (95% CI 99-100%) | Prospective | 378 Neg |
2. Sample Sizes and Data Provenance
-
Test Set for Agreement vs. Comparator Device:
- Total Samples: 267 retrospective samples.
- Matrix types: unpreserved frozen (42), C&S (15), SAF (139), and formalin (71).
- Country of Origin: Not explicitly stated, but the studies were conducted at 3 external laboratories. Given the "US and Canada" mention for overall sample collection, it's likely from these regions.
- Retrospective/Prospective: Retrospective.
-
Test Set for Sensitivity/Specificity vs. DFA Microscopy (Retrospective):
- Total Samples: 241 (91 positive, 150 negative).
- Positive matrix types: formalin (48), SAF (13), unpreserved frozen (17), Cary Blair (3), and C&S (10).
- Negative matrix types: formalin (42), SAF (70), unpreserved frozen (25), Cary Blair (3), and C&S (10).
- Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
- Retrospective/Prospective: Retrospective.
-
Test Set for Additional Retrospective Studies (Non-Fluorescent Microscopy):
- Site 2 (Wheatley's Stain): 67 retrospective samples (22 positive, 45 negative).
- Site 3 (Iron Hematoxylin Stain): 259 retrospective samples (60 positive, 199 negative).
- Country of Origin: Not explicitly stated, but likely from "US and Canada."
- Retrospective/Prospective: Retrospective.
-
Test Set for Prospective Study (DFA Microscopy):
- Total Samples: 378 negative samples.
- Matrix types: unpreserved fresh (153), unpreserved frozen (45), formalin (45), SAF (45), C&S (45), and Cary Blair (45).
- Country of Origin: Not explicitly stated, but collected from "Hospitals throughout the US and Canada."
- Retrospective/Prospective: Prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the "number of experts" used to establish ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience"). However, the ground truth methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain) are laboratory diagnostic techniques typically performed by trained medical technologists or laboratory personnel. It implies that these established methods served as the expert-level reference.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by the reference methods (DFA microscopy, Wheatley's Stain, Iron Hematoxylin Stain). In cases where the Uni-Gold device and the initial comparator device disagreed (e.g., in the "Agreement vs. Comparator Device" study), further resolution was sought through DFA microscopy or Iron Hematoxylin Stain, which effectively acted as an adjudicator to determine the true positive/negative status for those discrepant samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done. The study compares the device performance to established laboratory methods or an existing comparator device, not the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, standalone performance was evaluated. The studies directly compare the Uni-Gold™ Giardia device's results (algorithm only, as it's a rapid immunoassay) against the chosen established ground truth methods (DFA microscopy, non-fluorescent microscopy, or a comparator device). There is no "human-in-the-loop" aspect to the device's reading mechanism described.
7. Type of Ground Truth Used
The types of ground truth used were primarily:
- DFA Microscopy: Direct Fluorescent Antibody microscopy.
- Non-Fluorescent Microscopy: Specifically, Wheatley's Stain and Iron Hematoxylin Stain.
- Comparator Device: Remel Xpect™ Giardia Lateral Flow Assay (510K #: K031942) for initial agreement studies, with discrepant results often adjudicated by DFA or Iron Hematoxylin Stain.
8. Sample Size for the Training Set
The document describes a rapid immunoassay device. It does not mention a "training set" in the context of machine learning. The device is a chemical/immunological test, not an algorithm that requires a training set in the AI sense. The development of the assay itself would have involved internal validation and optimization, but not a distinct "training set" as understood in AI studies.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI algorithm, this question is not applicable to the Uni-Gold™ Giardia immunoassay device.
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MAR 1 2013
,
| 510(k) Summary – Uni-Gold™ Giardia | ||
|---|---|---|
| ------------------------------------ | -- | -- |
| 510(k)NumberAssigned: | K120001 |
|---|---|
| Introduction: | Trinity Biotech hereby submits this 510(k) summary for the Uni-Gold™ Giardia RapidLateral Flow Test Kit in accordance with the requirements of 21 CFR 807.92(C). |
| Submitter'sIdentification:Name &Address: | MarDx Diagnostics,a Trinity Biotech Company,5919 Farnsworth Ct.Carlsbad, CA. 92008, USA. |
| Contact: | Contact Person: Bonnie DeJoy, Corporate VP of RA (Official Correspondent)Email:Bonnie.DeJoy@TrinityUSA.ComAddress:2823 Girts RoadJamestown, NY 14701Phone:716-483-3851 Extension 1030Fax:716-488-1990 |
| DateSummaryPrepared: | February 21, 2013 |
| Device TradeName: | Uni-Gold™ Giardia |
| ClassificationName: | Entamoeba histolytica serological reagents.Giardia SPP 866.3220 Code MHI |
| ClassificationProductCode: | MHI |
| Intended Use: | Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitativedetection of Giardia lamblia ( G. lamblia ) antigens in human stool specimens. This test isintended for use with patients with gastrointestinal symptoms as an aid in the diagnosisof suspected Giardia gastrointestinal infections. As with other Giardia tests, resultsshould be considered in conjunction with the clinical evaluation and medical history. ForIn-Vitro Diagnostic use. |
| PredicateDevice | Remel Xpect™ Giardia Lateral Flow Assay (510K #: K031942) |
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Device Description
The Trinity Biotech Uni-Gold™ Giardia was designed as a single use, rapid, lateral flow immunoassay test device to detect the presence of Giardia lamblia antigen in unpreserved (fresh & frozen), preserved and media containing human stool specimens.
The Trinity Biotech Uni-Gold™ Giardia test strip (5mm x 60mm) combines a Nitrocellulose Membrane with designated fiber pads (conjugate, sample and absorbant). The test strip is then placed into a plastic housing and is sealed constituting the Test Device.
Picture A- Giardia Test Strip - 5 mm x 60 mm
Image /page/1/Figure/7 description: This image shows a diagram of a lateral flow assay test strip and its components. The test strip consists of a sample pad, conjugate pad, nitrocellulose membrane, absorbent pad, and backing. A plastic housing device is also shown, which is used to hold the test strip.
The Giardia Nitrocellulose Membrane Test Strip - above consist of
- A) Mouse anti-Giardia lamblia antibody is coated onto the Test Line region of the test strip.
- B) Rabbit anti-Goat IgG antibody is coated onto the Control Line region of the Test Strip.
- C) Goat anti- Giardia lamblia antibodies and Goat IgG antibodies are conjugated to red latex particles and dried onto the inert glass fiber (Conjugate Pad) which is inserted into the test strip below the nitrocellulose zone.
When Giardia antigens are present in the sample they combine with the antibody/red latex complex. As the complex migrates it binds to the antibodies in the test region forming a visible pink/red band. (Picture B) This forms the basis for the double antibody sandwich assay. Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device. This internal control line is to ensure and indicate that the test device is functioning correctly.
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Picture B- Giardia Test Device
Image /page/2/Figure/4 description: The image shows a diagram of a test strip and a test cassette. The test strip has labels indicating the location of the "Control Line" and the "Test Line". The test cassette has labels indicating the location of the "Test Result Window" and the "Sample Well".
The plastic housing device contains a window where the diluted stool sample is added (Sample Well) and a window above where the results are read in 15 minutes.
The test concept:
Mouse anti-Giardia lamblia is coated onto the test line region of the nitrocellulose zone of the test strip. Rabbit anti- Goat IgG is coated onto the control line region.
Goat anti-Giardia lamblia antibodies are conjugated to red latex particles and dried onto inert glass fiber. This is inserted into the test strip below the nitrocellulose zone.
A buffered solution is added to a dilution tube followed by the addition of the stool specimen (2 drops) via a disposable pipette. This mixture is then dispensed in total into the sample well of the lateral flow cartridge device with a dropper pipette and migrates through a pad containing red microspheres that have been coated with a antibody specific for the Giardia antigen. If the antigen is present, an immune complex forms. The migration continues along the membrane, which contains a striped down anti Giardia capture antibody. If Giardia antigen is present, the immune complex reacts with the anti-Giardia antibody at the test line on the membrane.
Thus Giardia antigens present in the sample combine with the antibody/red latex. As this complex migrates it binds to the antibodies in the test region forming a visible pink/red band.
Excess conjugate forms a second pink/red band in the control region of the device. The control line should always appear as a visible pink/red band in the control region of the device to indicate that the test device is functioning correctly.
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Comparison with Predicate Device
The predicate device and Uni-Gold™ Giardia use similar lateral flow technology and concepts. The following table provides a comparative summary for both device design features. Any differences in technology do not raise additional concerns regarding safety and effectiveness. Safety and effectiveness are demonstrated to be substantially equivalent.
| Aspect or Feature | ||
|---|---|---|
| Comparison Table | ||
| IntendedUse | (Remel -K031942) | Trinity BiotechUni-Gold™ Giardia |
| Detection of Giardiaantigens in fecalspecimens. | Detection of Giardia antigensin stool (fecal) specimens. | |
| Technology | Qualitativeimmunochromatographicassay | Qualitativeimmunochromatographicassay |
| Captureantibodiesonmembrane | Rabbit anti-Giardia, goatanti- mouse IgG | Mouse anti-Giardia lamblia,Rabbit anti-Goat IgG |
| Material:Membrane | Mylar-backed Nitrocellulose | Nitrocellulose |
| Conjugateantibodies | Monoclonal anti-Giardia,Normal Mouse IgG | Goat anti-Giardia lamblia,Goat IgG antibodies |
| MaterialConjugate: | Anti-Giardia and mouseIgG colored polystyreneparticles diluted in buffer | Anti-Giardia and Goat IgGcolored latex dried ontoconjugate pad |
| SpecimenTypes | Human Stool preserved in10% formalin, SAF, or CaryBlair | Human Stool: Fresh/Frozen,preserved (10% formalin orSAF) or provided in CaryBlair, or C&S TransportMedium |
| Samplevolume | 100 μl | 2 drops- approximately 40-60μl |
5919 Farnsworth Court • Carisbad, California • 92008 • USA • 760-929-0500 • Fax: 760-929-0124
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Precision /
An Intra-run precision/reproducibility study was performed at 3 sites including one internal site. This study consisted of 6 blind proficiency panel members, varying in reactivity: (2) Low Positive, (2) High Positive and (2) Negative samples. This Reproducibility panel was tested for a period of 5 days. Each site generated 2 runs per day, by two individual technicians totaling 20 replicates per site per panel member, i.e. 12C replicates total. 100% reproducibility was observed for all sites, for all days using the blind panel sample set, therefore 100% of the 120 samples tested for Giardia produced the expected result.
An additional Intra-run precision/reproducibility study was performed internal internally. This study consisted of 12 blind proficiency panel members, varying in reactivity: (4) Low Positive, (4) High Positive and (4) Negative samples. This panel was tested for a period of 5 days. Each site generated 2 runs per day, by two individual technicians totaling 20 replicates per panel member. 100% reproducibility was observed for all days using the blind panel sample set, therefore 100% of the samples tested for Giardia produced the expected result.
The Trinity Biotech Uni-Gold™ Giardia (1206610) along with Uni-Gold™ Giardia Control kit (1206611) was evaluated at 3 external laboratories. A total of 267 retrospective samples were tested side by side on the test device and a commercially available lateral flow device at three external sites in the following stool matrix types: unpreserved frozen (42), C&S (15), SAF (139), and formalin
(71).. The percent agreement of Uni-Gold™ Giardia versus the comparator device was as follows.
| Site 1 | Giardia | Comparator Device | % Agr | |
|---|---|---|---|---|
| + | - | |||
| Uni-Gold™ | + | 26 | 3* | 100% Pos Agr |
| - | 0 | 48 | 94.1% Neg Agr | |
| Site 2 | Giardia | Comparator Device | % Agr | |
| + | - | |||
| Uni-Gold™ | + | 51 | 0 | 100% Pos Agr |
| - | 0 | 49 | 100% Neg Agr |
| Site 3 | Giardia | Comparator Device | % Agr | |
|---|---|---|---|---|
| + | - | |||
| Uni-Gold™ | + | 54 | 6** | 100% Pos Agr |
| - | 0 | 30 | 83.3% Neg Agr |
- At Site 1, the 3 samples that tested positive on Uni-Gold 100 Giardia and negative on the comparator device were positive by DFA microscopy in
agreement with the Uni-Gold™ Giardia result.
** At Site 3, the 6 samples that tested positive on Uni-Gold™ Giardia and negative on the comparator device were positive by Iron Hematoxylin Stain
Percent Correlation
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microscopy in agreement with the Uni-Gold™ Giardia result.
No cross reactivity was observed using samples containing the following organisms: Adenovirus serotypes 3, 5, 7, 40, 41, Aeromonas hydrophila, Ascaris Iumbricoides, Bacteroides fragilis, Bacillus cereus, Bacillus subtilis, Blastocystis hominis, Campylobacter coli, Campylobacter fetus, Campylobacter jejuni, Candida albicans, Chilomastix mesnili, Clostridium difficile, Clostridium biffermentans, Coronavirus OC43, Coxsackievirus, Cryptosporidium parvum, Cyclspora cayetanensis, Cytomegalovirus (CMV), Dientamoeba fragilis. Diphyllobothrium latum. Echovirus 20. Endolimax nana. Entamoeba coli, Entamoeba hartmanni. Entamoeba histolytica. Cross Enterobius vermincularis. Enterococcus faecalis. Escherichia coli. Reactivity Escherichia coli 0157H7, Hookworm, Hymenolepis nana, lodamoeba butschlii. Isospora sp., Klebsiella pneumoniae, Microsporidia. Salmonella typhimurium. Shigella dysenteriae. Shigella flexneri. Shigella sonnei, Staphylococcus aureua, Staphylococcus aureus (Cowan's). Staphylococcus epidermidis. Strongyloides stercoralis. Taenia sp., Trichurius trichiura, Vibrio parahaemolyticus, and Yersinia enterocolitica.
Cross Reactivity has not been established for E. dispar.
Interfering Substance
The analytical specificity of the test was determined in stool samples containing potentially interfering substances at clinically relevant concentrations. Compounds were respectively spiked into positive and negative samples at medically relevant dosages (treatment). All treatments, including the unspiked (neat) positive and unspiked (neat) negative samples were tested in duplicate with Uni-Gold™ Giardia. The following compounds were tested: Human blood (20% v/v), Mucin (10% w/v), Stool fat (Triglycerides 0.14mg/ml or Stearic Acid 20% v/v), Pepto-Bismol (Bismuth) (20% v/v), Imodium A-D (Loperamide HCl) (20% v/v), Kaopectate (Attapugite) (20% v/v), Vancomycin (0.6mg/ml), K-Y jelly (0.289mg/ml), Vasoline (0.22mg/ml), Condom lubricant (1.716mg/ml), Maalox (magnesium hydroxide, calcium carbonate) (20% v/v), Tagamet (Cimetidine) (2.0x102 mg/ml), Pepsid (Famotidine) (6.0x104 mg/ml), Zantac (Ranitidine) (6.0×10 ³ mg/ml), Prilosec (Omeprazole) (6.0x103 mg/ml), Nitrazoxanide (6.96x103 mg/ml), Atovaquone (0.031mg/ml), Azithromycin (1.2x102 mg/ml), Metronidazole (0.12mg/ml), Paromomycin (0.42mg/ml), Trimethoprimsulfamethoxazole (TRM 0.04mg/ml & Sulf 0.4mg/ml). No test interference was observed by any of the compounds at the concentrations tested.
Sensitivity/ Specificity
The Trinity Biotech Uni-Gold™ Giardia (1206610) along with Uni-Gold™ Giardia Control kit (1206611) was evaluated at 4 external laboratories. The sensitivity and specificity of the test was compared against DFA microscopy with retrospective samples at sites 1 and 2 as shown in the following table.
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| Giardia | DFA Microscopy | ||
|---|---|---|---|
| + | - | ||
| Site 1 | Uni-Gold™ | 37 | 0 |
| 0 | 117 | ||
| Site 2 | Uni-Gold™ | 54 | 0 |
| 0 | 33 | ||
| Total | Uni-Gold™ | 91 | 0 |
| 0 | 150 |
Sensitivity: 100% (91/91) 95%Cl 95 - 100% Specificity: 100% (150/150) 95%Cl 97 - 100%
The positive samples were tested in the following matrix types: formalin (48), SAF (13), unpreserved frozen (17), Cary Blair (3), and C&S (10). The negative samples were tested in the following matrix types: formalin (42), SAF (70), unpreserved frozen (25). Cary Blair (3), and C&S (10)
Additional retrospective studies
Performance of the test was compared to non-fluorescent microscopy (staining) at two external laboratories. At site 2, 67 retrospective samples were evaluated and demonstrated a Positive Percent Agreement (PPA) of 100% (22/22) and a Negative Percent Agreement (NPA) of 100% (45/45) versus Wheatley's Stain, At site 3, 259 retrospective samples were evaluated and demonstrated a PPA of 100% (60/60) and aNPA of 100% (199/199) versus Iron Hematoxylin Stain.
Prospective Study
The following table shows a summary of test performance compared against DFA microscopy with prospective samples at site 4.
| Site 4 | Giardia | Giardia DFA | ||
|---|---|---|---|---|
| + | - | |||
| Uni-Gold™ | + | 0 | 0 | |
| - | 0 | 378 |
Specificity: 100% (378/378) 95% C1 99 - 100%
Due to infection prevalence, no positive samples were encountered during this prospective study. Samples were tested in the following sample matrix types: unpreserved fresh (153), unpreserved frozen (45), formalin (45), SAF (45), C&S (45), and Cary Blair (45).
Expected Values
The performance of the Uni-Gold Giardia™ Test Kit was evaluated at four external laboratories. The 945 (prospective and retrospective) samples were collected from Hospitals throughout the US and Canada and consisted of both male and female patients, of all ages from pediatric to adult, who presented with gastrointestinal symptoms. The retrospective study included 173 positive samples and 394 negative samples confirmed by microscopy. The prospective study included 378 samples which were subsequently confirmed neqative by microscopy. There were no differences observed in clinical performance between
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males or females, or between pediatric or adult populations.
Substantial Equivalence
conclusion
The information submitted in this premarket notification is complete and supports a substantial equivalence decision.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 1, 2013
Trinity Biotech C/O Bonnie DeJoy 5919 Farnsworth Ct. Carlsbad, CA 92008
Re: K120001
Trade Name: Uni-Gold™ Giardia Regulation Number: 21 CFR 866.3220 Regulation Name: Entamoeba histolytica serological reagents Regulatory Class: Class II Product Code: MHI Dated: February 22, 2013 Received: February 25, 2013
Dear Ms. DeJoy:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 -- Bonnie B. DeJoy
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sally A. Hojyat@
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): ________ K120001
Device Name: Uni-Gold™ Giardia
Indications for Use:
Trinity Biotech Uni-Gold™ Giardia is a single use rapid immunoassay for the qualitative detection of Giardia lamblia (G. lamblia) antigens in human stool specimens. This test is intended for use with patients with gastrointestinal symptoms as an aid in the diagnosis of suspected Giordio gastrointestinal infections. As with other Giardia tests, results should be considered in conjunction with the clinical evaluation and medical history. For In-Vitro Diagnostic use.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Vitro Diagnostic Devices (OIVD) Raquel A. Peat -S 2013.02.28 15:00:03 -05'00'
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§ 866.3220
Entamoeba histolytica serological reagents.(a)
Identification. Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toEntamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyEntamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasiteEntamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.