K Number

Device Name

IMMUNOCYT

Manufacturer

DIAGNOCURE, INC.

Date Cleared

2000-02-23

(62 days)

Product Code

NBK

Regulation Number

864.1860

Intended Use

ImmunoCyt is a qualitative direct immunocytofluorescence assay intended for use in conjunction with cytology to increase the overall sensitivity for the detection of tumor cells exfoliated in the urine of patients previously diagnosed with bladder cancer. ImmunoCyt is indicated for use as an aid in the management of bladder cancer in conjunction with urinary cytology and cystoscopy.

Device Description

ImmunoCyt is an in vitro diagnostic device that contains a solution of three monoclonal antibodies. Two antibodies are reactive to epitopes selectively detected on a mucin found in bladder cancer cells, and one antibody reacts with a bladder cancer-associated glycosylated form of the carcinoembryonic antigen. The antibodies are coupled with fluorescent markers. This solution is used to detect tumor cells exfoliated in the urine of bladder cancer patients. ImmunoCyt also contains a sample fixative and a blocking solution, as well as positive and negative control cells.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K964151, K970353

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a qualitative immunocytofluorescence assay using monoclonal antibodies and fluorescent markers. There is no mention of image processing, AI, DNN, or ML in the provided text.

Therapeutic

No.
ImmunoCyt is an in vitro diagnostic device used to detect tumor cells. It is not used for treating blader cancer nor does it claim or imply any therapeutic use.

Diagnostic

Yes
The device description explicitly states, "ImmunoCyt is an in vitro diagnostic device." Additionally, its intended use is to aid in the detection of tumor cells and the management of bladder cancer, which are diagnostic purposes.

SaMD (Software as a Medical Device)

The device description clearly states it is an in vitro diagnostic device containing a solution of monoclonal antibodies, a sample fixative, a blocking solution, and control cells, which are all physical components, not software.

IVD (In Vitro Diagnostic)

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

The "Device Description" explicitly states: "ImmunoCyt is an in vitro diagnostic device that contains a solution of three monoclonal antibodies."

Furthermore, the "Intended Use / Indications for Use" describes a test performed on a biological sample (urine) outside of the body to detect tumor cells, which is the definition of an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

NBK

Device Description

ImmunoCyt also contains a sample fixative and a blocking solution, as well as positive and negative control cells. The purpose of the blocking solution is to minimize non-specific binding of the antibodies. The purpose of the sample fixative is to optimize the quality of the cells isolated from urine by stabilizing the pH and decreasing crystals, mucus and other potential sources of artifacts in staining. Positive and negative control cells are to be used with each test sample preparation as qualitative indicators of the adequacy of the technique, reagents and instruments.

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

Clinical performance: Samples were collected from 14 hospital centers in Canada and were mixed with an equivalent volume of ethanol and stored refrigerated until processing at DiagnoCure's laboratories in Sainte-Foy (Québec), Canada. The clinical sensitivity of ImmunoCyt was established using urine samples from a panel of 87 patients with bladder tumor recurrences confirmed by histology. The clinical specificity of ImmunoCyt was established using urine samples from a panel of 154 patients with negative cystoscopy while being followed for bladder tumor recurrence. Specificity was also tested on urine samples from a panel of 170 normal individuals (without genitourinary symptoms) and on urine samples from a panel of 100 patients with various genitourinary disorders other than bladder cancer, as established by cystoscopy.

Reproducibility: Within-reader variability was determined using three readers from three different laboratories, each performing triplicate and blinded reading of one panel of three patient slides, and one panel of three mock samples, positive for each level of positivity in both panels. Between-reader variability was determined using nine readers from three different laboratories, each reader performing single and blinded reading of a panel of nine mock samples. Between-laboratory variability was determined using three laboratories, each reader performing single and blinded reading of a panel of three patient slides for each level of positivity.

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

Clinical performance study:

Clinical sensitivity established using urine samples from 87 patients with bladder tumor recurrences confirmed by histology.
Clinical specificity established using urine samples from 154 patients with negative cystoscopy while being followed for bladder tumor recurrence.
Specificity also tested on urine samples from 170 normal individuals (without genitourinary symptoms) and 100 patients with various genitourinary disorders other than bladder cancer.
Overall sensitivity: 94.3%
Overall specificity (Monitored for bladder cancer with no evidence of disease): 50.0%

Reproducibility study:

Within-reader variability: Mean of 0.44% for negative mock samples, 5.11% for positive mock samples, 21.67% for highly positive mock samples. For patient slides, mean of 0.33% for negative, 6.00% for positive, 1.78% for highly positive.
Between-reader variability: Mean of 0.41% for negative mock samples, 5.44% for positive mock samples, 35.26% for highly positive mock samples.
Between-laboratory variability (patient slides): Mean of 0.17% for negative, 2.75% for positive, 2.67% for highly positive.
Concordance rates:
- Mock Samples, Within Reader, negative: ~89% (~51.8%-99.7%)
- Mock Samples, Between Reader, negative: ~85% (~66.3%-95.8%)
- Mock Samples, Within Reader, positive/highly positive: ~83% (~58.6%-96.4%)
- Mock Samples, Between Reader, positive/highly positive: ~87% (~75.1%-94.6%)
- Patient Slides, Within Reader, negative: ~67% (~29.9%-92.5%)
- Patient Slides, Between Laboratory, negative: ~58% (~27.7%-84.8%)
- Patient Slides, Within Reader, positive/highly positive: 100% (81.5%-100%)
- Patient Slides, Between Laboratory, positive/highly positive: ~96% (~78.9%-99.9%)
- Total All: ~86% (80.8%-91.2%)

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

Sensitivity: 94%
Specificity: 50%
Monitoring sensitivity: 94.3% (86.5-97.9%, 95% confidence interval)
Monitoring specificity: 50.0% (41.9-58.1%, 95% confidence interval)

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.

K964151, K970353

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).

Not Found

Regulation Number and Section

§ 864.1860 Immunohistochemistry reagents and kits.

(a)
Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.

Summary

l. 510(k) Summary

510(k) number: K994356

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

A. Submitter's information

Name:	DiagnoCure Inc.
Address:	2050 René-Lévesque Ouest, 6th floor
Sainte-Foy, Québec
Canada, G1V 2K8
Telephone:	418-527-6100
Fax Number:	418-527-0240
Contact person:	Pierre Pelletier
Date prepared:	February 7, 2000

B. Device information

Name of device:	ImmunoCyt
Trade name:	ImmunoCyt™
Common Name:	Immunocytofluorescence assay
Classification Name:	Immunohistochemistry kit

C. Predicate devices

ImmunoCyt is substantially equivalent to these currently marketed devices:

#1 Predicate Device:	Bard BTA stat Test
Manufacturer:	Bainbridge Sciences Inc.,
Subsidiary of C.R. Bard Inc.
Redmond, Washington
510(k) Number:	K964151
#2 Predicate Device:	Auratek FDP
Manufacturer:	Organon Teknika, B.V.
Applicant:	Perimmune Inc.
1330 Piccard Dr.
Rockville, MD 20850
510(k) Number:	K970353

Premarket Notification

Device description D.

Intended use and indications ய்

ட் Technological characteristics

ImmunoCyt, the in vitro diagnostic device presented in this 510(k) submission is substantially equivalent to two currently marketed devices: the AuraTek FDP and the BARD BTA stat Test. All three devices are indicated to measure the presence of bladderassociated markers in the urine of patients already diagnosed with bladder cancer, and are based upon the use of antibodies. However, the analytes detected in each system are different. All three devices are indicated for use in conjunction with cystoscopy.

Substantial equivalence comparison table

Intended
use	ImmunoCyt is a
qualitative direct
immunocytofluorescence
assay intended for use in
conjunction with cytology
to increase the overall
sensitivity for the
detection of tumor cells
exfoliated in the urine of
patients previously
diagnosed with bladder
cancer.	The Bard BTA stat test is
an in vitro immunoassay
intended for the
qualitative detection of
bladder tumor associated
antigen in urine of
persons diagnosed with
bladder cancer.	AuraTek FPD is a rapid
one-step gold dye
particle lateral flow
immunoassay indicated
for the in vitro qualitative
measurement of
fibrinogen and
fibrin/fibrinogen
degradation products
(FDP) in human urine.
Indication	Indicated for use as an
aid in the management
of bladder cancer in
conjunction with urinary
cytology and cystoscopy.	Indicated for use as an
aid in the management
of bladder cancer
patients, in conjunction
with cystoscopy.	To be used with standard
cystoscopic examination
to aid in the
management of patients
with a history of bladder
cancer.
Format	Immunocytofluorescence
assay	Immunoassay	Immunoassay
Reagents	Antibody-based	Antibody-based	Antibody-based
Sample
Matrix	Urine	Urine	Urine
Analyte	Cell-associated antigens
M344, LDQ10, 19A211	A human complement
factor H-related protein	Fibrinogen and
Fibrin/fibrinogen
degradation products
Sensitivity	94%	66%	67%
Specificity	50%	80%	70%

Substantial equivalence comparison table

The three tests are intended to detect the presence of bladder The through urine sample analysis, but they each measure a tumors through unne 'sample' analytes are all related to the presence of bladder tumors.

G. Summary of studies

Clinical performance

Samples were collected from 14 hospital centers in Canada and were mixed with an equivalent volume of ethanol and stored refrigerated until processing at DiagnoCure's laboratories in Sainte-Foy (Québec), Canada. The clinical sensitivity of ImmunoCyt was established using urine samples from a panel of 87 patients with bladder tumor recurrences confirmed by histology. The clinical specificity of ImmunoCyt was established using urine samples from a panel of 154 patients with negative cystoscopy while being followed for bladder tumor recurrence. Specificity was also tested on urine samples from a panel of 170 normal individuals (without genitourinary symptoms) and on urine samples from a panel of 100 patients with various genitourinary disorders other than bladder cancer, as established by cystoscopy.

	1	2	3	Ta	T1	T2+	Tis	Total
1	21	45	21	52	23	7	5	87
38.1	38.1	48.9	66.7	46.2	43.5	85.7	80.0	50.6
19.0	19.0	33.9	43.1	32.5	23.9	42.0	29.9	39.7
61.3	61.3	64.0	84.5	60.4	65.1	99.2	98.9	61.4
95.2	95.2	93.3	95.2	96.2	95.7	85.7	80.0	94.3
74.1	74.1	80.7	74.1	85.7	76.0	42.0	29.9	86.5
99.8	99.8	98.3	99.8	99.3	99.8	99.2	98.9	97.9
95.2	95.2	97.8	100	96.2	100	100	100	97.7
74.1	74.1	86.8	86.7	85.7	87.8	65.2	54.9	91.2
99.8	99.8	99.9	100	99.3	100	100	100	99.6

Sensitivity Results by Stage and Grade (percentage)

Kev to tables 1, and 2:

N: Number, P: Proportion; L: Lower bound of 95% confidence interva; Ly; Upper bound of 95% confidence interval

Specificity Results by Condition (percentage)

	N	P	L	I	C	E	S	N	I	S
Normal asymptomatic	170	100	98.3	100	77.1	69.9	83.0	77.1	69.9	83.0
GU disorders
Prostate cancer	15	100	81.9	100	46.7	22.3	72.6	46.7	22.3	72.6
Inflammation	24	100	88.3	100	62.5	40.8	80.5	62.5	40.8	80.5
BPH	25	100	88.7	100	32.0	15.7	53.6	32.0	15.7	53.6
Hematuria	13	100	79.4	100	46.2	20.4	73.9	46.2	20.4	73.9
Lithiasis	8	100	68.8	100	37.5	10.2	74.1	37.5	10.2	74.1
GU conditions*	15	100	81.9	100	46.7	22.3	72.6	46.7	22.3	72.6
Total	100	100	97.0	100	46.0	36.1	56.2	46.0	36.1	56.2
Monitored for bladder cancer with no evidence of disease	154	94.8	89.7	97.6	50.0	41.9	58.1	49.4	41.3	57.5

Various genitourinary disorders including: vesical atony, urinational urinary disfunding, and hematuria Varrous genitous may usorders moduling. Vestair atterry, orinal y has with and hematuria.

otal
		154	241
Negative			82
Positive	ದ		159
1 1 1 1 2 10 10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
A Surville and and the	charges and manded the land in the man in in in in in include be handlish banding and and in the man and in the manner and work in the mainer and world in the mainer and worl

Comparison of ImmunoCyt and Cystoscopy in Detection of Recurrent Bladder Cancers

Monitoring sensitivity: Monitoring specificity: 94.3% (86.5-97.9%, 95% confidence interval) 50.0% (41.9-58.1%, 95% confidence interval)

Reproducibility 2.

Within-reader variability was determined using three readers from villnin-reader vanability was each performing triplicate and blinded three unferent laboratorise, outsing there patient slides and one panel of three reading of one panel of three-partive for each level of positivity in both panels. Between-reader variability was determined using nine parels. Between roader vanabing.
readers from three different laboratories, each reader performing readers from three different laboration of a panel of nine mock samples slides, Single and blinded foundy of positivity. Between-laboratory three slides for our vanability was dotominous as a reader performing single and blinded reading of a laboratones, odon roads. four slides for each level of positivity.

Descriptive statistics

| Within
Reader | Mock
Samples | - | 0 | 4 | 0.44 | 1.33 | 0 | 0 | 0.00 | 0.00 |
|-------------------|-------------------|----|---|----|-------|-------|---|-----|-------|-------|
| | | + | 0 | 16 | 5.11 | 5.51 | 0 | 3 | 1.33 | 1.12 |
| | | ++ | 7 | 31 | 21.67 | 10.01 | 1 | 17 | 9.11 | 6.17 |
| Between
Reader | Mock
Samples | - | 0 | 9 | 0.41 | 1.74 | 0 | 2 | 0.19 | 0.56 |
| | | + | 0 | 18 | 5.44 | 6.62 | 0 | 9 | 1.67 | 2.27 |
| | | ++ | 7 | 81 | 35.26 | 22.74 | 3 | 65 | 14.70 | 12.22 |
| Within
Reader | Patient
Slides | - | 0 | 1 | 0.33 | 0.50 | 0 | 0 | 0.00 | 0.00 |
| | | + | 1 | 13 | 6.00 | 4.44 | 1 | 21 | 6.11 | 6.49 |
| | | ++ | 1 | 5 | 1.78 | 1.39 | 1 | 193 | 54.67 | 61.01 |
| Between
Lab. | Patient
Slides | - | 0 | 1 | 0.17 | 0.39 | 0 | 4 | 0.67 | 1.37 |
| | | + | 0 | 5 | 2.75 | 1.96 | 0 | 4 | 0.83 | 1.19 |
| | | ++ | 0 | 9 | 2.67 | 3.73 | 1 | 30 | 12.83 | 9.86 |

Concordance rates

| Mock

Samples	-	Within Reader	3/3	3/3	2/3	8/9	89% (51.8%-99.7%)
		Between Reader	8/9	9/9	6/9	23/27	85% (66.3%-95.8%)
	+/++	Within Reader	6/6	6/6	3/6	15/18	83% (58.6%-96.4%)
		Between Reader	12/18	18/18	17/18	47/54	87% (75.1%-94.6%)
Patient
Slides	-	Within Reader	3/3	0/3	3/3	6/9	67% (29.9%-92.5%)
		Between Laboratory	3/4	4/4	0/4	7/12	58% (27.7%-84.8%)
	+/++	Within Reader	6/6	6/6	6/6	18/18	100% (81.5%-100%)
		Between Laboratory	7/8	8/8	8/8	23/24	96% (78.9%-99.9%)
Total	-/+/++	All	48/57	54/57	45/57	147/171	86% (80.8%-91.2%)
			84.2%	94.7%	78.9%

3. Interfering substances

Testing has been conducted to identify cross-reactivity between the ImmunoCyt kit and potential contaminants in urine specimens. The specific objectives were to establish whether the presence of contaminants: 1) induced false positivity on negative samples, and 2) extinguished positivity on positive samples. Proteinaceous contaminants included white blood cells, red blood cells, albumin, and immunoglobulin. All were from human origin. Microbial contaminants included: Candida albicans, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa. All microbial contaminants came from ATCC. Each test condition was conducted on three urine samples from different donors or patients, and at two pH levels (5.0 and 8.0).

Albumin	$10 \text{ mg}$	$10 \text{ mg}$
γ-globulin	$0.625 \text{ mg}$	$0.625 \text{ mg}$
White blood cells	$5 \times 10^4 \text{ cells}$	$5 \times 10^4 \text{ cells}$
Red blood cells	$1 \times 10^6 \text{ cells}$	$1 \times 10^6 \text{ cells}$
Candida albicans	$1 \times 10^8 \text{ cells}$	$1 \times 10^8 \text{ cells}$
Escherichia coli	$1 \times 10^8 \text{ cells}$	$1 \times 10^8 \text{ cells}$
Staphylococcus aureus	$1 \times 10^8 \text{ cells}$	$1 \times 10^8 \text{ cells}$
Pseudomonas aeruginosa	$1 \times 10^8 \text{ cells}$	$1 \times 10^8 \text{ cells}$

Interfering Substances

The effects of intravesical therapy with BCG or chemotherapy on the specificity of ImmunoCyt have not been established. Test results from samples of patients who have received such should be treated carefully.

H. Conclusions

The safety and effectiveness data demonstrate how the performance of ImmunoCyt compares to the legally now the devices, Bard BTA stat test and AuraTek FDP. Furthermone the data substantiate the basic performance claim of the product, and to increase the overall sensitivity of urinary cytology for the detection of turnor cells exfoliated in the urine of patients previously diagnosed with bladder cancer.

DEPARTMENT OF HEALTH & HUMAN SERVICES

FEB 23 2000

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DiagnoCure, Inc. c/o Dr. Bruce F. Mackler Heller Fhrman White and McAuliffe, LLP 815 Connecticut Avenue, N.W., Suite 200 Washington, D.C. 20006-4004

Re: K994356 Trade Name: ImmunoCytTM Regulatory Class: II Product Code: NBK Dated: December 22, 1999 Received: December 23, 1999

Dear Dr. Mackler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moponents, are regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device to a legally market to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of Compliance and please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation information on your responsibilities under (30 ) 34-4039. "Also, please note the regulation
information on your responsibilities under the Anton's (21CFR 807.97). Other gene information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at is internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.I)., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use Statement

Applicant: DiagnoCure Inc.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ImmunoCyt

Indications for use:

ImmunoCyt is a qualitative direct immunocytofluorescence assay intended for use in conjunction with cytology to increase the overall sensitivity for the detection of turnor cells exfoliated in the urine of patients previously diagnosed with bladder cancer . ImmunoCyt is indicated for use as an aid in the management of bladder cancer in conjunction with urinary cytology and cystoscopy.

Peter E. Mackin

(Division Sign-Off)
Division of Clinical Laboratory Devices K994356
510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V OR Over-The-Counter Use (Per 21 C.F.R. 801.109) (Optional Format 1-2-96)