AllTest Strep A Rapid Test
Device Facts
| Record ID | K260342 |
|---|---|
| Device Name | AllTest Strep A Rapid Test |
| Applicant | Hangzhou AllTest Biotech Co., Ltd. |
| Product Code | GTY · Microbiology |
| Decision Date | Apr 30, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
| Attributes | Pediatric |
Indications for Use
The AllTest Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes (Group A β-hemolytic Streptococcus, Strep A) antigens in throat swab specimens from patients with signs and symptoms of pharyngitis to aid in the diagnosis of Group A Streptococcus infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
Device Story
Lateral flow immunoassay for qualitative detection of Strep A carbohydrate antigen in throat swab specimens; utilizes rabbit anti-Strep A antibodies coated on test line and gold-particle-conjugated antibodies; specimen extraction followed by membrane migration; colored line at test region indicates positive result; procedural control line confirms proper wicking; performed by healthcare professionals in clinical settings; results aid diagnosis of Group A Streptococcus infection; negative results require confirmation by bacterial culture; provides rapid visual readout to support clinical decision-making.
Clinical Evidence
Prospective clinical study of 525 fresh throat swab specimens across four U.S. sites. Comparator: bacterial culture and organism ID. Results: 121 culture-positive, 404 culture-negative. Sensitivity: 95.0% (95% CI: 89.6-97.7%); Specificity: 99.0% (95% CI: 97.5-99.6%).
Technological Characteristics
Lateral flow immunochromatographic assay; rabbit anti-Strep A antibodies; gold particle conjugation; cassette form factor; visual readout; shelf life 24 months at 2-30°C; no electronic components or software.
Indications for Use
Indicated for symptomatic patients of all ages presenting with pharyngitis signs/symptoms to aid in Group A Streptococcus infection diagnosis. Negative results require confirmation by bacterial culture.
Regulatory Classification
Identification
Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.
Predicate Devices
- Wondfo® One Step Strep A Swab Test (K133343)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K260342
B Applicant
Hangzhou AllTest Biotech Co., Ltd.
C Proprietary and Established Names
AllTest Strep A Rapid Test
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GTY | Class I | 21 CFR 866.3740 - Streptococcus spp. serological reagents. | MI - Microbiology |
## II Submission/Device Overview:
A Purpose for Submission:
To obtain a substantial equivalence determination for the AllTest Strep A Rapid Test.
B Measurand:
Group A $\beta$-hemolytic Streptococcus (GAS; Streptococcus pyogenes) antigens in throat swab specimens.
C Type of Test:
Lateral flow chromatographic immunoassay
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The AllTest Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of *Streptococcus pyogenes* (Group A β-hemolytic *Streptococcus*, Strep A) antigens in throat swab specimens from patients with signs and symptoms of pharyngitis to aid in the diagnosis of Group A *Streptococcus* infection.
All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A *Streptococcus* and should not be used as the sole basis for treatment.
C Special Conditions for Use Statement(s):
- Rx-For Prescription Use Only
- For *in vitro* diagnostic use only
- A negative result must be confirmed by culture. A negative result may be obtained if the concentration of the Group A Streptococcus antigen present in the throat swab is not adequate or is below the detectable level of the test.
D Special Instrument Requirements:
N/A
IV Device/System Characteristics:
A Device Description:
The AllTest Strep A Rapid Test a qualitative, chromatographic lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab specimen from symptomatic patients. Antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. During testing, a throat swab from the patient is collected and the Strep A antigen is extracted in an extraction tube. When applied to the test cassette, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a colored (red) line in the test line region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line should always appear in the control line region, indicating that proper volume of specimen has been added, and membrane wicking has occurred. If the control line does not appear, the test result is invalid. Results can be read after 5 minutes.
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Kit Contents:
- Test Cassettes
- Extraction Tubes
- Sterile Swabs
- Dropper Tips
- Extraction Reagent 1 (2M Sodium nitrite, 0.004g/L Phenol red)
- Extraction Reagent 2 (5.763g/L Citric acid, 0.4ml/L Proclin 300)
- Positive Control (Heat-inactivated Group A Streptococcus)
- Negative Control (Heat-inactivated Group C Streptococcus)
- Package Insert
- Quick Reference Instructions
B Principle of Operation:
Group A Streptococcus antigen reacts with the anti-Strep A antibody conjugated to the gold particle. The complex is then bound by the anti-Strep A capture antibody and a visible red color test line appears, indicating a positive result. To serve as an onboard procedural control, a control line observed at the control site prior to running the assay will turn red, indicating that the test has been performed properly.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Wondfo Rapid Strep A Test
B Predicate 510(k) Number(s):
K133343
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K260342
(candidate device) | K133343
(predicate) |
| --- | --- | --- |
| Device Trade Name | AllTest Strep A Rapid Test | Wondfo Rapid Strep A Test |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The AllTest Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of | The Wondfo Strep A Rapid Test is a chromatographic immunoassay for the qualitative detection of Strep A antigen from throat |
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| Device & Predicate Device(s): | K260342
(candidate device) | K133343
(predicate) |
| --- | --- | --- |
| | Streptococcus pyogenes
(Group A β-hemolytic Streptococcus, Strep A)
antigens in throat swab specimens from patients with signs and symptoms of pharyngitis to aid in the diagnosis of Group A Streptococcus infection.
All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment. | swab specimens from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. This test is intended for professional and laboratory use, only |
| Specimen | Throat swab | Same |
| Test Technology | Immunochromatographic lateral flow assay | Same |
| Test Antibody | Rabbit anti Strep A | Same |
| Indication for Use | Prescription Use | Same |
| Test Result | Qualitative | Same |
| General Device Characteristic Differences | | |
| Test Format | Cassette | Strip |
| Results Reading Time | 5 minutes | 10 minutes |
| Clinical Sensitivity | 95.0% (95% CI: 89.6-97.7%) | 95 %: 95% CI (88-98%) |
| Clinical Specificity | 99.0% (95% CI: 97.5-99.6%) | 98%: 95% CI (96-99%) |
| Analytical Sensitivity | 2.0×10^{5} CFU/ml | 1.5×10^{5} CFU/mL |
VI Standards/Guidance Documents Referenced:
N/A
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
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1. Precision/Reproducibility:
To demonstrate the reproducibility of the Alltest Strep A Rapid Test, a four-member test panel consisting of contrived positive *Streptococcus pyogenes* ATCC 12365 samples prepared in negative clinical matrix (pooled negative clinical matrix from healthy volunteer throat swabs) at moderate positive (3 × LoD; 6.0×10⁵ CFU/mL), LoD (1 × LoD; 2.0×10⁵ CFU/mL) and low negative (0.5 × LoD; 1.0×10⁵ CFU/mL) concentrations, as well as a negative sample, was tested. The panel was tested at three sites by two blinded operators at each site. Each operator tested each panel member, in duplicate over five days using three lots of the device (2 operators × 3 sites × 2 replicates × 3 lots × 5 days = 180 results/panel member). The results are summarized in Table 1.
Table 1: Summary of Reproducibility of Alltest Strep A Rapid Test from all sites
| Samples | Positive Agreement % (Positive/Total tested) | | | Overall Positive Agreement % |
| --- | --- | --- | --- | --- |
| | Site A | Site B | Site C | |
| Moderate positive | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (180/180) |
| LoD sample | 96.7% (58/60) | 95.0% (57/60) | 95.0% (57/60) | 95.6% (172/180) |
| Low negative | 51.7% (31/60) | 46.7% (28/60) | 48.3% (29/60) | 48.9% (88/180) |
| True negative | 0% (0/60) | 0% (0/60) | 0% (0/60) | 0% (0/180) |
There were no significant differences in the test results obtained between different operators, sites, or lots on different days. The Alltest Strep A Rapid Test Device reproducibility is acceptable.
2. Linearity:
N/A
3. Analytical Specificity/Interference:
To prepare positive samples for the analytical studies, microorganisms were spiked into negative clinical matrix prepared from swabs collected from healthy subjects that were pooled and screened to be negative using an FDA-cleared test. Negative samples were prepared with negative clinical matrix only.
## Microbial Cross-Reactivity and Interference
A cross-reactivity study was conducted to evaluate the performance of the Alltest Strep A Rapid Test in the presence of 61 microorganisms commonly found in throat specimens that could potentially interfere with test results. The microorganisms tested included various streptococcal species (Groups B, C, D, F, and G), respiratory viruses (adenovirus, parainfluenza, RSV, rhinovirus, coronavirus, measles, mumps), bacterial pathogens (*Staphylococcus*, *Neisseria*, *Haemophilus*, *Mycobacterium*, *Enterococcus*, *Escherichia coli*, *Pseudomonas*), and other throat flora including yeast (*Candida albicans*). Each potentially cross-reacting microorganism was tested in replicates of three using six different device lots at clinically relevant levels of viruses (tested at ≥ 1.0 × 10⁵ TCID₅₀/mL) and bacteria/yeast (tested at ≥ 1.0 × 10⁶ CFU/mL). Samples were randomized, blinded, and tested according to the package insert instructions by three independent operators. There were no false positive reactions with any of the tested microorganisms at the specified concentrations, confirming
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that the Alltest Strep A Rapid Test does not cross-react with the tested bacteria, viruses, and yeast that may be present in throat specimens. See Table 2 below for results.
To evaluate microbial interference, the same panel of 61 microorganisms was evaluated in triplicate in the presence of $2 \times$ LoD of S. pyogenes ATCC #12365 ( $4 \times 10^{5}$ CFU/mL). All strain combinations were spiked into negative clinical matrix swabs from healthy subjects confirmed negative by commercial Strep A testing. No microbial interference was observed for any of the organisms at the concentrations tested, with all samples showing positive results for Streptococcus pyogenes detection despite the presence of potential interferents. See Table 2 below for results.
Table 2: Microbial Cross-reactivity and Interference of the Alltest Strep A Rapid Test
| Organism | Organism |
| --- | --- |
| Adenovirus 3 | Neisseria gonorrhoeae |
| Adenovirus 7 | Neisseria lactamica |
| Adenovirus Type I | Neisseria meningitides |
| Adenovirus Type II | Neisseria mucosa |
| Arcanobacterium haemolyticum | Neisseria sicca |
| Bordetella pertussis | Neisseria subflava |
| Candida albicans | Proteus vulgaris |
| Corynebacterium diphtheria | Pseudomonas aeruginosa |
| Cytomegalovirus | Respiratory syncytial virus Type A |
| Enterococcus faecalis | Respiratory syncytial virus Type B |
| Enterococcus faecium | Serratia marcescens |
| Enterovirus (VR-28 Human Coxsackievirus) | Staphylococcus aureus |
| Epstein Barr Virus | Staphylococcus epidermidis |
| Escherichia coli | Staphylococcus haemolyticus |
| Fusobacterium necrophorum | Staphylococcus marcescens |
| Haemophilus influenzae | Streptococcus agalactiae (Group B) |
| Haemophilus parahaemolyticus | Streptococcus anginosus (Group G) |
| Haemophilus parainfluenzae | Streptococcus dysgalactiae (Group C) |
| HSV Type 1 MacIntyre strain | Streptococcus mitis |
| Human coronavirus OC43 | Streptococcus mutans |
| Human metapneumovirus (HMPV-27 A2) | Streptococcus oralis |
| Human parainfluenza Type 1 | Streptococcus pneumoniae |
| Human parainfluenza Type 2 | Streptococcus salivarius |
| Human parainfluenza Type 3 | Streptococcus sanguis |
| Human rhinovirus 26 | Streptococcus sp. (bovis II) Group D |
| Klebsiella pneumoniae | Streptococcus sp. Strain H60R (Group F) |
| Lactobacillus sp. (Lactobacillus casei) | Yersinia enterocolitica |
| Legionella pneumophila | |
| Measles Virus | |
| Moraxella (Branhamella) catarrhalis | |
| Moraxella lacunata | |
| Mycobacterium tuberculosis | |
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| Organism | Organism |
| --- | --- |
| Mycobacterium tuberculosis (avirulent strain) | |
| Mumps virus | |
## Interfering Substances
An interfering substances study was conducted to evaluate the performance of the Alltest Strep A Rapid Test in the presence of endogenous and exogenous substances commonly found in throat specimens.27 substances were evaluated for potential to interfere with the test, including human blood, mucin, over-the-counter mouthwashes, throat sprays, cough syrups, throat lozenges, and active pharmaceutical ingredients commonly found in cold and allergy medications. Each substance was tested in replicates of three using three different device lots, both in the absence and presence of Streptococcus pyogenes (2×LoD, 4×10⁵ CFU/mL). Interfering substances were applied to swabs with negative clinical matrix from healthy subjects that were screened to be negative using an FDA-cleared GAS assay. The study was conducted in a randomized and blinded manner with three operators.
None of the 27 substances tested demonstrated a potential to cause false positive, false negative, or invalid results at the concentrations tested. All samples without S. pyogenes generated negative results, and all samples with S. pyogenes generated positive results, as expected. Results confirmed that the tested endogenous and exogenous substances did not interfere with test performance. See Table 3 below for a list of substances and concentrations tested.
Table 3: List of Endogenous and Exogenous Substances Tested
| Substance | Concentration |
| --- | --- |
| Blood (human), EDTA anticoagulated | 20% (v/v) |
| Mucin | 1 mg/mL |
| OTC Mouthwashes: | |
| Listerine Antiseptic Cool Mint | 20% (v/v) |
| Crest Pro-Health Clean Mint | 20% (v/v) |
| Crest Pro Health Multi Protection Clean Mint | 20% (v/v) |
| Colgate Total Pro-Shield, Spearmint | 20% (v/v) |
| OTC Lozenges: | |
| Sucrets Sore Throat & Cough Lozenges, Honey Lemon | 5 mg/mL |
| Sucrets Sore Throat Lozenges Cherry | 5 mg/mL |
| Halls Mentho-Lyptus Drops Cherry | 5 mg/mL |
| Halls Cough Suppressant Cherry Triple Soothing Action | 5 mg/mL |
| Cepacol Extra Strength Sore Throat & Cough Drop Lozenges, Cherry | 5 mg/mL |
| OTC Throat Sprays: | |
| Mucinex Sore Throat + Pain Relief | 20% (v/v) |
| Chloraseptic Max | 20% (v/v) |
| OTC Cough Syrups: | |
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| Substance | Concentration |
| --- | --- |
| Tylenol Cough and Sore Throat | 10% (v/v) |
| Basic Care Tussin DM, Cough Suppressant & Expectorant | 10% (v/v) |
| Robitussin (Guaifenesin Syrup) | 10% (v/v) |
| Robitussin Nighttime Cough | 10% (v/v) |
| Children's Dimetapp Cold & Flu | 10% (v/v) |
| Children's Dimetapp Cold & Cough | 10% (v/v) |
| Active Ingredients: | |
| Acetaminophen (Tylenol) | 5 mg/mL |
| Brompheniramine Maleate | 5 mg/mL |
| Chlorpheniramine Maleate | 5 mg/mL |
| Dextromethorphan HBr | 5 mg/mL |
| Diphenhydramine HCl | 5 mg/mL |
| Doxylamine Succinate | 5 mg/mL |
| Guaifenesin (Guaiacol Glyceryl) | 5 mg/mL |
| Ibuprofen (Advil) | 5 mg/mL |
| Phenylephrine HCl | 5 mg/mL |
## 4. Detection Limit and Assay Reportable Range:
### Limit of Detection
The limit of detection (LoD) of the AllTest Strep A Rapid Test was determined using contrived stocks of inactivated *S. pyogenes* (ATCC 12365) prepared in negative throat swab clinical matrix. Dilutions were applied to swabs with negative clinical matrix and swabs were processed according to the instructions for use. Preliminary testing was conducted with concentrations ranging from $6.0 \times 10^{3}$ to $6.0 \times 10^{8}$ CFU/mL using nine replicates per concentration across three lots. Confirmation studies were then performed with concentrations around the preliminary LoD using 21 replicates per concentration across three lots. Based on the confirmation study results, the limit of detection was established as $2.0 \times 10^{5}$ CFU/mL (equivalent to $1.0 \times 10^{4}$ CFU per swab). The results from the confirmatory LoD study are summarized in Table 4.
| Concentration Tested | Positive Replicates | % Positivity |
| --- | --- | --- |
| 6.0×10^{5} CFU/mL | 21/21 | 100% |
| 2.0×10^{5} CFU/mL | 20/21 | 95.2% |
| 1.0×10^{5} CFU/mL | 10/21 | 47.6% |
| 5.0×10^{4} CFU/mL | 3/21 | 14.3% |
| 2.0×10^{4} CFU/mL | 0/21 | 0% |
### Inclusivity Study
Inclusivity of the AllTest Strep A Rapid Test was examined with six *S. pyogenes* strains (ATCC 14289, 19615, 49399, 12344, 700294, and Zeptometrix strain 0801512) tested with nine replicates per strain using three lots. Strains were diluted and $50~\mathrm{uL}$ of each dilution was pipetted onto a swab with negative clinical matrix and swabs were processed according to the instructions for use. The study tested each strain concentration in triplicate across three lots.
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Results are shown in Table 5. The study results demonstrated that all six strains were correctly detected at concentrations similar to the reported LoD (2.0 × 10⁵ CFU/mL).
Table 5: Inclusivity Study Report
| S. pyogenes Strains | Detection Conc. (CFU/mL) | Positive/Tested | % Detection |
| --- | --- | --- | --- |
| ATCC# 14289 | 2.0x10⁴ | 9/9 | 100% |
| ATCC# 19615 | 1.0x10³ | 9/9 | 100% |
| ATCC# 49399 | 1.0x10⁴ | 9/9 | 100% |
| ATCC# 12344 | 5.0x10³ | 9/9 | 100% |
| ATCC# 700294 | 2.0x10⁴ | 9/9 | 100% |
| Zeptometrix 0801512 | 5.0x10⁵ | 9/9 | 100% |
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Quality Control
The Alltest Strep A Rapid Test incorporates three controls:
- Internal positive control: A red line appearing in the control (C) line region of the test is an internal procedural control intended to indicate that the test is functioning as expected. If the procedural control line does not develop, the test result is invalid, and retesting with a new device and sample is recommended.
- External controls: Positive and negative external controls are supplied with each kit. The positive external control includes heat-inactivated Group A Streptococcus and the negative external control includes heat-inactivated Group C Streptococcus. The device instructions for use recommend that a positive and negative external control be tested for new shipments of kits and for new operators to ensure the test is functioning as expected and the assay procedure is performed correctly.
Specimen Stability
A specimen stability study was conducted to evaluate if delays in specimen testing would impact the performance of the Alltest Strep A Rapid Test. Negative swab samples (negative clinical matrix only; five replicates) and positive swab samples contrived with Streptococcus pyogenes at 2×LoD (10 replicates) or 5×LoD (five replicates) were stored under two conditions: room temperature (15-30°C) for 0, 24, 48, and 72 hours, and refrigerated (2-8°C) for 0, 24, 72, and 96 hours. At each time point, specimens were tested using three lots, with each lot tested by one blinded operator who independently recorded results.
The results demonstrated 100% expected results across all tested conditions, with 100% concordance among operators and lots. All negative specimens remained negative (5/5), all 2×LoD positive specimens remained positive (10/10), and all 5×LoD positive specimens remained positive (5/5) at every time point tested. The study concluded that swab specimens are stable for up to 72 hours at room temperature and up to 96 hours when refrigerated at 2-8°C.
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6. Assay Cut-Off:
N/A
## B Comparison Studies:
1. Method Comparison with Predicate Device:
N/A
2. Matrix Comparison:
N/A
## C Clinical Studies:
1. Clinical Sensitivity:
Performance of the AllTest Strep A Rapid Test was established during a prospective clinical study. Subjects enrolled were symptomatic patients presenting with signs and symptoms of Strep A infection (pharyngitis) with completed informed consent prior to sample collection. Patient demographics included male and female patients across all ages.
Five hundred and twenty five (525) fresh throat swab specimens were prospectively collected at four geographically distinct sites across the United States. Two swabs were used to collect samples, one for the AllTest Strep A Rapid Test and the other for the bacterial culture and organism ID confirmation at a reference laboratory. A total of 13 operators were included across the study sites.
Bacterial culture was performed at CLIA-certified central clinical laboratories. Specimens were plated on blood agar plates and incubated following routine laboratory culture procedures for identifying S. pyogenes. Beta-hemolytic colonies from the blood agar plates were confirmed for Group A streptococci through appropriate identification methods. Of the 525 specimens tested, 121 (23.0%) were culture-positive and 404 (77.0%) were culture-negative.
The combined performance of the AllTest Strep A Rapid Test compared to reference culture results is summarized in Table 6. The performance stratified by each site is shown in Table 7.
Table 6: Overall Clinical Performance of AllTest Strep A Rapid Test
| AllTest Strep A Rapid Test | Culture Comparator | | |
| --- | --- | --- | --- |
| | Positive | Negative | Total |
| Positive | 115 | 4 | 119 |
| Negative | 6 | 400 | 406 |
| Total | 121 | 404 | 525 |
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| AllTest Strep A Rapid Test | Culture Comparator | | |
| --- | --- | --- | --- |
| | Positive | Negative | Total |
| Sensitivity | 95.0% (95% CI: 89.6%-97.7%) | | |
| Specificity | 99.0% (95% CI: 97.5%-99.6%) | | |
Table 7: Clinical Performance of AllTest Strep A Rapid Test Stratified by Site
| Site | Total | TP | FN | TN | FP | Sensitivity [95% CI] | Specificity [95% CI] |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Site 1 | 100 | 23 | 1 | 75 | 1 | 95.8% (23/24) [79.8%-99.3%] | 98.7% (75/76) [92.9%-99.8%] |
| Site 2 | 54 | 8 | 0 | 46 | 0 | 100% (8/8) [67.6%-100%] | 100% (46/46) [92.3%-100%] |
| Site 3 | 191 | 44 | 3 | 142 | 2 | 93.6% (44/47) [82.8%-97.8%] | 98.6% (142/144) [95.1%-99.6%] |
| Site 4 | 180 | 40 | 2 | 137 | 1 | 95.2% (40/42) [84.2%-98.7%] | 99.3% (137/138) [96.0%-99.9%] |
| All Sites | 525 | 115 | 6 | 400 | 4 | 95.0% (115/121) [89.6%-97.7%] | 99.0% (400/404) [97.5%-99.6%] |
TP = true positive, FN = false negative, TN = true negative, FP = false positive, CI = confidence interval
2. Clinical Specificity: See above.
3. Clinical Cut-Off: N/A
4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): N/A
# D Expected Values/Reference Range:
In the multi-center clinical study conducted to evaluate the AllTest Strep A Rapid Test from four sites in the United States, $23.0\%$ (121/525) of patients presenting with symptoms of Strep A were found to be culture positive for Strep A.
The prevalence stratified by age group is shown in Table 8.
Table 8: Prevalence Stratified by Age
| Age | Number of Samples per Age Range (% of Total Samples) | Number of Positives by Reference Method (% Prevalence by Age Group) |
| --- | --- | --- |
| 0–5 | 207 (39.4%) | 58 (28.0%) |
| 6–21 | 271 (51.6%) | 55 (20.3%) |
| 21+ | 47 (9.0%) | 8 (17.0%) |
| All Ages | 525 (100%) | 121 (23.0%) |
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VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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