(197 days)
P940018
P940018
No
The device description details a standard immunochromatographic assay, and there are no mentions of AI, ML, image processing, or any other computational methods typically associated with AI/ML in the summary. The performance studies describe traditional clinical trial methodologies.
No
The device is an in vitro diagnostic immunoassay used for qualitative detection of bladder tumor associated antigen, intended as an aid in the management of bladder cancer patients. It does not provide treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic immunoassay" and "is indicated for use as an aid in the management of bladder cancer patients."
No
The device description clearly indicates it is an immunochromatographic assay utilizing monoclonal antibodies and involves adding patient urine to a sample well, which are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states "The BTA stat test is an in vitro diagnostic immunoassay...". This is the most direct confirmation.
- Device Description: The description details an "immunochromatographic assay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine." This describes a test performed on a biological sample (urine) outside of the body to diagnose or aid in the management of a condition.
- Performance Studies: The document describes clinical sensitivity and specificity studies using urine samples from patients and individuals, which are typical performance evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (P940018 - Bard® BTA® Test) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
N/A
Intended Use / Indications for Use
The BTA stat test is an in vitro diagnostic immunoassay indicated for the qualitative detection of bladder turnor associated antigen in urine of persons diagnosed with bladder cancer. This test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.
The BTA stat test is a qualitative test indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.
Product codes
Not Found
Device Description
The BTA stat test for bladder tumor associated antigen is an immunochromatographic assay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine. Patient urine is added to the sample well and allowed to react with a colloidal gold-conjugated antibody. If the antigen is present in the sample, an antigen conjugate complex is formed and a line in the patient (P) test zone appears.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A subset of the patients studied (181) also had the Bard BTA test performed on the same sample as the BTA stat test.
A subset of the patients with histologically confirmed blacider cancer (131) also had voided urine cytology (VUC) performed on the same semple as the BTA stat test.
BTA stat test specificity (Table VI) was cistermined using urine samples from 555 individuals with no history of bladder cancer. Samples were collected from 5 different may and the no have you intelles. United States and stored fremen (-80 degrees C) until instact. Testing of samples for this study was periormed at Bard Diagnostic Sciences, Inc. The average age was 55 years, 52% were fornalse, 80% were caucasion, 8% African American, 4% Asian, Hispanic or other, and 3% of unionown ethnicky.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CLINICAL SENSITIVITY: BTA stat test sensibily (Table ) was cleters and senter were collection and and and and and and and one of the man and and and and and and and Incl. Teelig of semple for this study we performed at 07% canode Societ assemble Inc. Themge of senties for this study we performed at 7% canada Stations of Addesse, presented below by stage and by grade of the turnor.
STUDY TYPE: Clinical Sensitivity
SAMPLE SIZE:
- Ta: 111
- T1: 38
-
=T2: 50
- Tis: 18
- Grade 1: 57
- Grade 2: 58
- Grade 3: 95
KEY RESULTS: - Ta: 51% sensitivity
- T1: 90% sensitivity
-
=T2: 88% sensitivity
- Tis: 61% sensitivity
- Grade 1: 42% sensitivity
- Grade 2: 66% sensitivity
- Grade 3: 83% sensitivity
STUDY TYPE: Comparison of BTA stat Test to Bard BTA Test
SAMPLE SIZE: 181
KEY RESULTS: In this study the Berd BTA test had a sensitivity of 50% while the STA stat toot had a sensitivity of 66% (p=0.233).
STUDY TYPE: Clinical Sensitivity (Monitoring sensitivity and specificity)
KEY RESULTS:
- Monitoring sensitivity = 67% (60 - 73, 96% confidence interval)
- Monitoring specificity = 70% (61 - 79, 96% confidence interval)
STUDY TYPE: HYPOTHETICAL POSITIVE PREDICTIVE VALUES (PPV) AND NEGATIVE PREDICTIVE VALUES (4PV)
KEY RESULTS:
- For 10% Bladder Cancer Recurrence Prevalence: PPV = 19.8, NPV = 95.0
- For 20% Bladder Cancer Recurrence Prevalence: PPV = 35.8, NPV = 89.4
- For 30% Bladder Cancer Recurrence Prevalence: PPV = 48.8, NPV = 83.1
STUDY TYPE: BTA stat TEST AND VUC SENSITIVITIES
SAMPLE SIZE: 131
KEY RESULTS: The BTA stat tast was shown to be more sensible than VUC in all categories except ior Tis (tumor in situ).
- Ta: BTA stat 45%, VUC 7%, BTA stat + VUC 49%
- T1: BTA stat 85%, VUC 41%, BTA stat + VUC 85%
-
=T2: BTA stat 75%, VUC 38%, BTA stat + VUC 81%
- Tis: BTA stat 53%, VUC 60%, BTA stat + VUC 80%
STUDY TYPE: Clinical Specificity (BTA stat test vs VUC for patients with history of bladder cancer and no evidence of disease)
SAMPLE SIZE: 96
KEY RESULTS: the specificity of the BTAstattest was 68% compared to VUC with a specificity of 97%.
STUDY TYPE: BTA stat TEST SPECIFICITY REBULTS
SAMPLE SIZE: 555 total subjects with no history of blacider canosr
KEY RESULTS:
- Healthy Subjects (167): 95% Test Negative
- Non-smokers (100): 93% Test Negative
- Smokers (67): 97% Test Negative
- Non-Genitourinary Benign Diseases and Cancers (105): 93% Test Negative
- Non-Genitourinary Benign Diseases (52): 96% Test Negative
- Non-Genitourinary Cancers (53): 89% Test Negative
- Genitourinary Diseases (152): 72% Test Negative
- BPH (26): 88% Test Negative
- Benign Renal Disease (32): 50% Test Negative
- Misc. GU Disease (94): 76% Test Negative
- UTI/cystitis (30): 60% Test Negative
- STD (24): 79% Test Negative
- Other (40): 85% Test Negative
- Genitourinary Cancers (77): 73% Test Negative
- Prostate Cancers (45): 78% Test Negative
- Renal Cancers (7): 29% Test Negative
- Renal TCC (1): 0% Test Negative
- Renal Cell Carcinoma (6): 33% Test Negative
- Other Cancers (25): 76% Test Negative
- Genitourinary Trauma (54): 33% Test Negative
- History of Bladder Cancer - No Evidence of Disease (107): 70% Test Negative
STUDY TYPE: HIGH DOSE HOOK EFFECT
KEY RESULTS: - Hich does hook (prozone) effect tests were conducted to determine if the BTA stat isset is free from interference from high concentration por ent sumples. Results showed . that there was no prozone offect up to 12,400 Umi. blad ler turnor associated antigen in a patient's urine semple, which was the highest concentration available for testing.
STUDY TYPE: REPRODUCIBILITY
KEY RESULTS: - Three lots of BTA stat devices were used for the reproducibility studies to determine day to-day, reader to-reader and lot-to-lot variability. These studies were consisted by sory reproduct readers for each ict of devices. Betw . Were son k 2007 of 4 b conducted at these laboratories by testing 10 rep as on one lot of BTA stat devices. All reproductibility studies showed nearly total ag mant with the exception of samples near the limit of detection, which is to be expected for qua tests.
STUDY TYPE: INTERFERING SUBSTANCES
KEY RESULTS: Normal and TCC positive urine pools containing the substances listed below were tected in the BTAstat test.
- Possible Urine Constituents:
- Hemoglobin: No interference at MLT* (100 mg/dL)
- White Blood Cells: No interference at MLT (10^6 cells/mL)
- Red Blood Cells: No interference at MLT (10^6 cells/mL)
- Albumin: No interference at MLT (1 g/dL)
- Bilirubin (unconjugated): Interfered at 0.8 mg/dL^ (no interference at 0.4 mg/dL)
- IgG: No interference at MLT (10 mg/dL)
- Uric Acid: No interference at MLT (250 mg/dL)
- Ascorbic Acid: No interference at MLT (5 g/dL)
- Caffeine: Interfered at 117 mg/dL^ (no interference at 58.3 mg/dL)
- Nicotine: Interfered at 28 mg/dL^ (no interference at 14 mg/dL)
- Sodium chloride: Interfered at 730 mg/dL^ (no interference at 365 mg/dL)
- Ethanol: No interference at MLT (1% (v/v))
- Possible Microbial Contaminants:
- Candida albicans: Interfered at 2.5 x 10^6 CFU/mL (no interference at 1.25 x 10^6 CFU/mL)
- Escherichia coli: No interference at MLT (2.5 x 10^6 CFU/mL)
- Pseudomonas aerugenosa: No interference at MLT (2.5 x 10^6 CFU/mL)
- Therapeutic Agents:
- Ampicillin: No interference at MLT (600 mg/dL)
- Acetaminophen: Interfered at 5.2 g/dL^ (no interference at 520 mg/dL)
- Acetyl Salicylic Acid: Interfered at 5.2 g/dL^ (no interference at 520 mg/dL)
- Doxorubicin-HCl: No interference at MLT (10 mg/dL)
- Mitomycin C: No interference at MLT (10 mg/dL)
- Nitrofurantoin: No interference at MLT (50 mg/dL)
- Phenazopyridine-HCl: Interfered at 100 mg/dL^ (no interference at 80 mg/dL)
- Thiotepa: No interference at MLT (10 mg/dL)
- Trimethoprim: No interference at MLT (50 mg/dL)
- Bacillus Calmette Guerin: No interference at MLT (20 mg/dL)
- Finasteride: No interference at MLT (2.5 mg/dL)
- Flutamide: No interference at MLT (100 mg/dL)
- Ioversol, 74% (imaging contrast agent): Interfered at 5%^ (no interference at 1%)
- Uriced: Interfered at 35 mg/dL° (no interference at 17.5 mg/dL)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Monitoring sensitivity = 67% (60 - 73, 96% confidence interval)
Monitoring specificity = 70% (61 - 79, 96% confidence interval)
For 10% Bladder Cancer Recurrence Prevalence: PPV = 19.8, NPV = 95.0
For 20% Bladder Cancer Recurrence Prevalence: PPV = 35.8, NPV = 89.4
For 30% Bladder Cancer Recurrence Prevalence: PPV = 48.8, NPV = 83.1
Predicate Device(s)
P940018
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
K92461
APR 16 1997
510(k) SUMMARY INFORMATION
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter's Information: A.
Submitter's Name: Address: Contact Person: Contact Person's Phone: Contact Person's Fax: Date of Preparation:
Device Name: B.
Trade Name: Common / Usual Name: Classification Name:
Bard Diagnostic Sciences, Inc. 12277 134th Ct., NE Glen Paul Freiberg (206) 814-1520 (206) 814-1521 September 11, 1996
Bard® BTA stat™ Test BTA stat™Test Tumor Associated Antigen Immunological Test System
C. Predicate Device Name:
Trade Name:
Bard® BTA® Test P940018 - Reclassified to Class II
Bard Diagnostic Sciences, Inc., claims substantial equivalence to the above mentioned test.
1
510(k) SUMMARY INFORMATION Bard BTA stat Test Page 2
- The BTA stat test for bladder tumor associated antigen is D. Device Description: an immunochromatographic assay utilizing monoclonal antibodies to specifically detect the presence of bladder tumor associated antigen in urine. Patient urine is added to the sample well and allowed to react with a colloidal gold-conjugated antibody. If the antigen is present in the sample, an antigen conjugate complex is formed and a line in the patient (P) test zone appears.
E. Intended Use:
The BTA stat test is an in vitro diagnostic immunoassay indicated for the qualitative detection of bladder turnor associated antigen in urine of persons diagnosed with bladder cancer. This test is indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.
F. Indications for Use:
The BTA stat test is a qualitative test indicated for use as an aid in the management of bladder cancer patients in conjunction with cystoscopy.
G. Substantial Equivalence & Technological Characteristics Summary:
The Bard BTA stat Test and the Bard BTA Test are both rapid format qualitative assays. The Bard BTA stat test is a lateral flow assay which detects antigen though antigen-specific antibodies. The Bard BTA Test is a test strip assay which detects "bladder tumor associated analytes" through an agglutination interaction with IgG coated latex particles. Both assays are intended for management of bladder cancer patients, but they detect different substances.
2
EXPECTED RESULTS
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CLINICAL SENSITIVITY
BTA stat test sensibily (Table ) was cleters and senter were collection and and and and and and and one of the man and and and and and and and and Incl. Teelig of semple for this study we performed at 07% canode Societ assemble
Inc. Themge of senties for this study we performed at 7% canada Stations of Addesse, presented below by stage and by grade of the turnor.
| Table I. BTA stat TEST SENSITIVITY BY STARE AND GRADE- | 1.2 | |
|---|---|---|
| STAGE | N | SENSITIVITY (%) |
|---|---|---|
| Ta | 111 | 51 |
| T1 | 38 | 90 |
| ≥T2 | 50 | 88 |
| Tis | 18 | 61 |
| GRADE | N | SENSITIVITY (%) |
| 1 | 57 | 42 |
| 2 | 58 | 66 |
| 3 | 95 | 83 |
*3 patients without stage and 12 without grade determinations.
A subset of the patients studied (181) also had the Bard BTA test performed on the same sample as the BTA stat test. In this study the Berd BTA test had a sensitivity of 50% while the STA stat toot had a sensitivity of 66% (p=0.233).
| Table II, COMPARISON OF BTA stat TEST TO BARD BTA TEST | ||||||
|---|---|---|---|---|---|---|
| 1:10 TTA | |||||
|---|---|---|---|---|---|
| And acc | |||||
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Tible II presents the ventily in 220 patents with historges
Table III. BTA stat TIEST REBULTS FROM PATIENTS With a History of Bladder Cancer
| 17. | |||
|---|---|---|---|
| 10000 | |||
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| ----- | |||
| A Charles Children Children | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ||
| A | 0 | ||
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| Active a career | -------- | 3 | BUCK CARDED |
Monitoring sensitivity = 67% (60 - 73, 96% confidence interval)
Monitoring specificity = 70% (61 - 79, 96% confidence interval)
Using the data in Table III and a 10%, 20%, and 30% hypothetical prevalonce of bladder oomg to aller in the a rela a 1970 2014 and see with proclicity the blesse of the cystoscopy, the true specificity in these psitents and the positive and negative preciletive values are likely to be higher.
Table IV, HYPOTHETICAL POSITIVE PREDICTIVE VALUES (PPV) AND NEGATIVE PREDICTIVE VALUES (4PV) OF THE ISTA stat TEST
| BLADDER CANCER
RECURRENCE
| PREVALENCE | PPV | NPV |
|---|---|---|
| 10% | 19.8 | 95.0 |
| 20% | 35.8 | 89.4 |
| 30% | 48.8 | 83.1 |
- . '· : · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
3
A subset of the patients with histologically confirmed blacider cancer (131) also had voided urine cytology (VUC) performed on the same semple as the BTA stat test (Table V). The BTA stat tast was shown to be more sensible than VUC in all categories except ior Tis (tumor in situ).
| STAGE | N | SENSITIVITY
BTA stat (%) | SENSITIVITY
VUC (%) | SENSITIVITY
BTA stat + VUC (%) |
|-------|----|-----------------------------|------------------------|-----------------------------------|
| Ta | 73 | 45 | 7 | 49 |
| T1 | 27 | 85 | 41 | 85 |
| ≥T2 | 16 | 75 | 38 | 81 |
| Tis | 15 | 53 | 60 | 80 |
Table V. BTA stat TEST AND VUC SENSITIVITIES
in a subset of patients (96) with a history of blackler cancer and no evidence of disease the specificity of the BTAstattest was 68% compared to VUC with a specificity of 97%.
CLINICAL SPECIFICITY
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BTA stat test specificity (Table VI) was cistermined using urine samples from 555 individuals with no history of bladder cancer. Samples were collected from 5 different may and the no have you intelles. United States and stored fremen (-80°C) until instact. Testing of samples for this study was periormed at Bard Diagnostic Sciences, Inc. The average age was 55 years, 52% were fornalse, 80% were caucasion, 8% African American, 4% Asian, Hispanic or other, and 3% of unionown ethnicky. The normal healthy cancers (71% of samples provided by formated) included cliabetee, arthrille, lupus our (of 1 % of campos province by charactive dasvesse, as well as louismin
erythemas, breast, lang and gastroinselles The non-blection (nonalded (pensi il as leulosmia, s) consisted of prostate, renal coll cancers category (60% of samples provided by make comes. The GU disease category renal TCC, endometrial, ovarian and other GU on (52% of samples provided by fornalse) occasions with beness, urinery tracter infections (UT), incontinence, sexually transmilled diseases (STD) and other disorders.
The realite indicated that heathy inclivity in the was 20%, respective). Posted on the many and and patients with renal cancer including upper tract TCC. Expected results may vary depending on the patient population tested.
| PATIENT TYPE | NUMBER OF
SUBJECTS | TEST
NEGATIVE (%) |
|-------------------------------------------------------|-----------------------|----------------------|
| Healthy Subjects | 167 | 95 |
| Non-smokers | 100 | 93 |
| Smokers | 67 | 97 |
| Non-Genitourinary Benign Diseases
and Cancers | 105 | 93 |
| Non-Genitourinary Benign Diseases | 52 | 96 |
| Non-Genitourinary Cancers | 53 | 89 |
| Genitourinary Diseases | 152 | 72 |
| BPH | 26 | 88 |
| Benign Renal Disease | 32 | 50 |
| Misc. GU Disease | 94 | 76 |
| UTI/cystitis | 30 | 60 |
| STD | 24 | 79 |
| Other | 40 | 85 |
| Genitourinary Cancers | 77 | 73 |
| Prostate Cancers | 45 | 78 |
| Renal Cancers | 7 | 29 |
| Renal TCC | 1 | 0 |
| Renal Cell Carcinoma | 6 | 33 |
| Other Cancers | 25 | 76 |
| Genitourinary Trauma | 54 | 33 |
| TOTAL | 555 | NA |
| History of Bladder Cancer -
No Evidence of Disease | 107 | 70 |
Table VI. BTA stat TEST SPECIFICITY REBULTS
total of subjects with no history of blacider canosr
No evidence of disease confirmed by cystoscopy and/or biopsy; 78% of patients in this category were males.
4
PERFORMANCE CHARACTERISTICS
HIGH DOSE HOOK EFFECT
Hich does hook (prozone) effect tests were conducted to determine if the BTA stat isset is free from interference from high concentration por ent sumples. Results showed . that there was no prozone offect up to 12,400 Umi. blad ler turnor associated antigen in a patient's urine semple, which was the highest concentration available for testing.
REPRODUCIBILITY
Three lots of BTA stat devices were used for the reproducibility studies to determine day to-day, reader to-reader and lot-to-lot variability. These studies were consisted by sory reproduct readers for each ict of devices. Betw . Were son k 2007 of 4 b conducted at these laboratories by testing 10 rep as on one lot of BTA stat devices. All reproductibility studies showed nearly total ag mant with the exception of samples near the limit of detection, which is to be expected for qua tests.
INTERFERING SUBSTANCES
Normal and TCC positive urine pools containing the substances listed below were tected in the BTAstat test.
| SUBSTANCE | HIGHEST LEVEL
TESTED WITH NO
INTERFERENCE | LEVEL AT WHICH
SUBSTANCE
INTERFERED |
|-------------------------------------------|-------------------------------------------------|-------------------------------------------|
| Possible Urine Constituents | | |
| Hemoglobin | 100 mg/dL | No interference at MLT* |
| White Blood Cells | $10^6$ cells/mL | No interference at MLT |
| Red Blood Cells | $10^6$ cells/mL | No interference at MLT |
| Albumin | 1 g/dL | No interference at MLT |
| Bilirubin (unconjugated) | 0.4 mg/dL | 0.8 mg/dL^ |
| IgG | 10 mg/dL | No interference at MLT |
| Uric Acid | 250 mg/dL | No interference at MLT |
| Ascorbic Acid | 5 g/dL | No interference at MLT |
| Caffeine | 58.3 mg/dL | 117 mg/dL^ |
| Nicotine | 14 mg/dL | 28 mg/dL^ |
| Sodium chloride | 365 mg/dL | 730 mg/dL^ |
| Ethanol | 1% (v/v) | No interference at MLT |
| Possible Microbial Contaminants | | |
| Candida albicans | 1.25 x $10^6$ CFU/mL | 2.5 x $10^6$ CFU/mL |
| Escherichia coli | 2.5 x $10^6$ CFU/mL | No interference at MLT º |
| Pseudomonas aerugenosa | 2.5 x $10^6$ CFU/mL | No interference at MLT º |
| Therapeutic Agents | | |
| Ampicillin | 600 mg/dL | No interference at MLT |
| Acetaminophen | 520 mg/dL | 5.2 g/dL^ |
| Acetyl Salicylic Acid | 520 mg/dL | 5.2 g/dL^ |
| Doxorubicin-HCl | 10 mg/dL | No interference at MLT |
| Mitomycin C | 10 mg/dL | No interference at MLT |
| Nitrofurantoin | 50 mg/dL | No interference at MLT |
| Phenazopyridine-HCl | 80 mg/dL | 100 mg/dL^ |
| Thiotepa | 10 mg/dL | No interference at MLT |
| Trimethoprim | 50 mg/dL | No interference at MLT |
| Bacillus Calmette Guerin | 20 mg/dL | No interference at MLT |
| Finasteride | 2.5 mg/dL | No interference at MLT |
| Flutamide | 100 mg/dL | No interference at MLT |
| Ioversol, 74% (imaging
contrast agent) | 1% | 5%^ |
| Uriced | 17.5 mg/dL | 35 mg/dL° |
Table VII. INTERFERING SUBSTANCES
MLT - maximum lawai tastad
Negative Interfarence: substance decreased the intensity of a TCC positive urine test result
Subjecting samples to one freeze/thaw cycle resulted in no interference at 1.25 x 10" CFU/mL,
the MIJ.
Results of Interior noe studies unchanged by subjecting samples to one freeze/thew cycle
Substance's coloration caused results for both normal and TCC positive urine to be difficuit to Reports
In conclusion, the Bard BTA stat Test is substantially equivalent to the predicate device referenced in this submission.