(19 days)
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.
The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
This document describes the DIASCREEN® Reagent Strip System for urinalysis, a dip-and-read test strip for semi-quantitative urinalysis.
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are not explicitly stated as numerical targets the device must meet in the provided text. Instead, the study aims to demonstrate substantial equivalence by showing high agreement (within the same color block or within one color block) between the DIASCREEN® Reagent Strips and a legally marketed predicate device (Bayer Multistix 10 SG). The reported device performance is presented as the percentage of agreement.
Here's a table summarizing the performance data, with the understanding that the "acceptance criteria" are implied by the observed high percentages of agreement with the predicate device.
| Analyte | Agreement within Same Color Block (DIASCREEN® Lot 1 vs. Bayer) | Agreement within 1 Color Block (DIASCREEN® Lot 1 vs. Bayer) | Agreement within Same Color Block (DIASCREEN® Lot 2 vs. Bayer) | Agreement within 1 Color Block (DIASCREEN® Lot 2 vs. Bayer) |
|---|---|---|---|---|
| Specific Gravity | 74% (39/53) | 100% (53/53) | 66% (35/53) | 100% (53/53) |
| Leukocyte | 79% (42/53) | 100% (53/53) | 81% (43/53) | 100% (53/53) |
| pH | 70% (37/53) | 100% (53/53) | 66% (35/53) | 100% (53/53) |
| Blood | 92% (49/53) | 100% (53/53) | 83% (44/53) | 100% (53/53) |
| Nitrite | 100% (53/53) | 100% (53/53) | 100% (53/53) | 100% (53/53) |
Note: The document also reports cross-lot consistency for DIASCREEN® (Lot 1 vs. Lot 2), showing high agreement (91-100% within the same color block and 100% within 1 color block).
2. Sample Size and Data Provenance:
- Test Set Sample Size: 53 fresh urine samples.
- Data Provenance: The urine samples were obtained from a "mixed patient population" at a "medical facility." The study was conducted in the US at Wichita State University (Kansas), though the manufacturer is based in Korea. The study appears to be prospective, as fresh urine samples were obtained and tested for the evaluation.
3. Number of Experts and Qualifications for Ground Truth:
The document does not explicitly state the number of experts used for establishing ground truth, nor their specific qualifications beyond the study director, James Jackson MT(ASCP) CLS, Ph.D. While the study director is qualified, it's not indicated if he acted as the sole expert for all ground truth determinations or if additional, similarly qualified personnel were involved in reading the strips and/or performing confirmation tests.
4. Adjudication Method for the Test Set:
The study involved a comparison between the DIASCREEN® Reagent Strips and the Bayer Multistix 10 SG. When data between the two products did not agree within one color block, an "alternate procedure" (confirmation test) was used. This implies an adjudication process where a third, more definitive method resolved discrepancies between the initial two readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the DIASCREEN® strips to a predicate device and to confirmative tests, not the improvement of human readers with vs. without AI assistance. The device is a visual dip-and-read strip, not an AI-assisted diagnostic tool in the sense of image analysis software.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the performance of the DIASCREEN® Reagent Strips themselves was evaluated independently against comparator methods and against a predicate device. The results are based on visual comparison with a color chart, which is the intended standalone use of the device. The study evaluates the algorithm of the test strip (i.e., its chemical reactions and color development) and the visual interpretation of results.
7. Type of Ground Truth Used:
The ground truth for the test set was established using a combination of:
- Predicate Device Comparison: Bayer Multistix 10 SG was used as a primary comparator.
- Confirmatory (Reference) Tests: For discrepancies (data not agreeing within one color block between DIASCREEN® and Bayer), specific confirmation tests were employed for each analyte:
- Specific Gravity: Refractometer
- Leukocyte: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)
- pH: pH Meter
- Blood: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim), Ascorbic Acid Test/Urispec (Henry Schein)
- Nitrite: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)
8. Sample Size for the Training Set:
The document does not provide information about a "training set" or its sample size. This type of device (visual reagent strip) does not typically involve machine learning or AI models that require specific training sets in the computational sense. The "development" of the strips would involve chemical formulation and calibration, rather than algorithmic training on a dataset.
9. How Ground Truth for the Training Set Was Established:
As no "training set" in the context of AI/machine learning is described, there is no information on how its ground truth was established. The "ground truth" for the performance evaluation in this document refers to the established values obtained from the predicate device and the confirmatory reference methods on the test set of urine samples.
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JUN 17 1997
Summary of Safety and Effectiveness
May 27, 1997
The following information is provided as a summary of safety and effectiveness information for the DIASCREEN® Reagent Strip System.
-
Common Name: Visual Reagent Test Strip for Urinalysis (a]
Trade/Proprietary Name: DIASCREEN® Reagent Strips, in many different configurations with as many different product codes. is the registered trademark of Dia-Screen DIASCREEN® Corporation. -
Establishment Registration Number: 9010673 [b]
Chung Do Pharmaceutical Co., Ltd. 312 Gaju-Dong Jin Hae-City Kyung Sang Nam-Do, 645-500 Korea. -
Vicki Frawley Contact Person: [c]
-
[d] Intended Use
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
- Product Description [e]
DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.
The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent
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strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
The directions must be followed exactly. Accurate timing is essential to provide optimal results. The reagent strips must be kept in the original bottle containing the desiccant with the cap tightly closed to maintain reagent activity. To obtain optimal results it is necessary to use fresh, well-mixed, uncentrifuged urine.
The DIASCREEN® Reagent Strips will be manufactured in Korea by Chunq Do Pharmaceutical CO., Ltd. of Seoul. Korea. They will be marketed in the United States by Dia-Screen Corporation. Dia-Screen is the exclusive United States distributor for Chung Do.
Dia-Screen Corporation has previously submitted 510k's on behalf of Chung Do Pharmaceutical Co., Ltd and Bioscan Instruments, Inc.(now defunct) under Dia-Screen Corporation's former name, Genesis Labs Inc. These are K940043 and K943008. In addition, Dia-Screen Corporation, which is a FDA registered facility, has received two 510k's for its own manufactured urine reagent strips. They are K961375 and K952971.
The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K940043, K943008) and DIASCREEN® (K952971, K961375) strips which were reviewed previously.
Substantial Equivalence િય
The intended use of the strips which are the subject of this new pre-market notification is exactly the same as the strips which were reviewed previously (K940043, K943008, K952971, K961375),
The design and function of the new DIASCREEN® Reagent Strips are the same as the design and function of both the Bioscan and DIASCREEN® Reagent Strips which have been previously reviewed under pre-market notifications K940043, K943008. K952971, and K961375.
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The DIASCREEN® Reagent Strips for Urinalysis are substantially equivalent to Bayer Multistix 10 SG, Behring Rapignost, Bioscan, and Boehringer Mannheim Chemstrip urine test strip systems.
Characteristics of the Bayer Multistix 10 SG and the Bioscan systems are compared with the DIA SCREEN® system in the following table:
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| This 510 (k) | Prevoius 510 (k) | Bayer Multistix 10 SG | |
|---|---|---|---|
| Strip Name | DIASCREEN® | Bioscan | Bayer |
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Reagents for: | |||
| Specific | Bromothymol blue | Bromthymol blue | Bromthymol blue |
| Gravity | Methyl red | Methyl vinyl ether/ | Poly (methyl vinyl-ethermaleic anhydride) |
| Polyvinyl phosphate | maleic acid copolymer | ||
| Leukocyte | 2-Phenylthiazole aminoacid esterDiazonium salt | Not offered | Derivatized pyrrole aminoacid esterDiazonium saltBuffer |
| Ketones | Sodium nitroprusside | Sodium nitroprusside | Sodium nitroprussideBuffer |
| Glucose | Glucose oxidasePeroxidasePotassium iodide | Glucose oxidasePeroxidasePotassium iodide | Glucose oxidasePeroxidasePotassium iodideBuffer |
| Protein | Tetrabromphenol blueCitric acidTrisodium citrate | Tetrabromphenol blueCitric acidTrisodium citrate | Tetrabromphenol blueBuffer |
| Blood | 2,5 Dimethylhexane-2,5-dihydroperoxide3,3',5,5'-Tetramethylbenzidine | 2,5 Dimethylhexane-2,5-dihydroperoxide3,3',5,5'-Tetramethylbenzidine | Diisopropylbenzene-dihydroperoxide3,3',5,5'-Tetramethylbenzidine |
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| Strip NameDistributorReagents for: | This 510 (k)DIASCREEN®Dia-Screen | Prevoius 510 (k)BioscanDia-Screen | Bayer Multistix 10 SGBayer |
|---|---|---|---|
| Nitrite | p-Arsanilic acidN-(1-naphthyl)ethylenediamine | p-Arsanilic acidN-(1-naphthyl)ethylenediamine | p-Arsanilic acid1,2,3,4-Tetrahydro-benzo(h)quinoline-3-olBuffer |
| pH | Bromthymol blueMethyl red | Bromthymol blueMethyl red | Bromthymol blueMethyl red |
| Bilirubin | 2,4 Dichlorobenzene-diazonium saltOxalic acid | 2,4 Dichlorobenzene-diazonium saltOxalic acid | 2,4-Dichloroaniline-diazonium saltBuffer |
| Urobilinogen | 4-methoxybenzene-diazonium saltCitric acid | 4-methoxybenzene-diazonium saltCitric acid | Diethylaminobenzaldehyde |
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| Strip NameDistributor | This 510 (k)DIA SCREEN® | Previous 510 (k)Bioscan | Multistix 10 SG |
|---|---|---|---|
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Packaged withDesiccant | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes |
| Time required toread strips | 10 to 120 seconds | 60 seconds | 30 to 120 seconds |
| Storage | Between 15 - 30 °C (59°-86° F). Do Not Store inrefrigerator or freezer. Donot expose to moisture,heat or light. | Between 15 - 30 °C (59°-86° F). Do Not Store inrefrigerator or freezer. Donot expose to moisture,heat or light | Between 15°- 30° C (59°-86° F) Do Not Store inDirect Sunlight |
t
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| This 510 (k) | Previous 510 (k) | Multistix 10 SG | |
|---|---|---|---|
| Strip Name | DIA SCREEN® | Bioscan | |
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Expected Values: | |||
| Specific Gravity | Random urines vary from1.001-1.035. Twenty-fourhour urines from normaladults with normal dietsand fluid intake will havea specific gravity of1.016-1.022 | Random urines vary from1.001-1.035. Twenty-fourhour urines from normaladults with normal dietsand fluid intake will havea specific gravity of1.016-1.022 | Random urines vary from1.001-1.035. Twenty-fourhour urines from normaladults with normal dietsand fluid intake will havea specific gravity of1.016-1.022 |
| Ketones | Should not be detected innormal urine. | Should not be detected innormal urine. | Normal specimens yieldnegative results. |
| Glucose | None found in normalurine. Concentrations of100 mg/dL may beconsidered abnormal. | None found in normalurine. Concentrations of100 mg/dL may beconsidered abnormal. | None found in normalurine. Concentration of100 mg/dL may beconsidered abnormal. |
| Protein | Normal specimensordinarily contain someprotein (0-4 mg/dL).Persistent results of traceor higher indicatesignificant proteinuria. | Normal specimensordinarily contain someprotein (0-4 mg/dL).Persistent results of traceor higher indicatesignificant proteinuria. | Normal specimensordinarily contain someprotein (0-4 mg/dL). Acolor matching any "+"block indicates significantproteinuria |
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| Strip NameDistributor | This 510 (k)DIA SCREEN®Dia-Screen | Previous 510 (k)BioscanDia-Screen | Multistix 10 SGBayer |
|---|---|---|---|
| Expected Values: | |||
| Blood | The practical detectionlimit of this test is 5 to 10erythrocytes per microliterof urine | The practical detectionlimit of this test is 5 to 10erythrocytes per microliterof urine | The significance of thetrace reaction may varyamong patients. Clinicaljudgement is required |
| Nitrite | Any degree of pink colorafter 30 secondsindicates clinicallysignificant bacteria | Any degree of pink colorafter 30 seconds indicatesclinically significantbacteria NA | Normally, no nitrite isdetectable in urine |
| pH | Normal urine has a pH of6 and urine pH valuesgenerally range from 5 to8 | Normal urine has a pH of6 and urine pH valuesgenerally range from 5 to8NA | Both the normal andabnormal pH range isfrom 5 to 9 pH units |
| Bilirubin | No bilirubin is detectablein urine of healthypersons | No bilirubin is detectablein urine of healthypersons | Normally, no bilirubin isdetectable in healthypersons |
| Urobilinogen | Normal range is 0.1 to 1.0mg/dL | N Normal range is 0.1 to1.0 mg/dL A | Normal range is 0.1 to1.0 Ehrlich units per 100ml |
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Clinical Laboratory Evaluation of DIASCREEN® Strips
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip intended for use as an in-vitro diagnostic aid using urine specimens. DIASCREEN® Reagent Strips have been developed to allow health care professionals to semi-quantitatively determine levels of specific gravity, ketone, alucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen in patient urine by visual comparison with a color chart of each concentration range. No additional reagents or laboratory equipment are required. These reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be maintained tightly capped in the plastic vial to assure reagent activity. The directions-for-use must be followed exactly.
An independent laboratory evaluation of the new DIASCREEN® Reagent Strips for Urinalysis was conducted under the direction of James Jackson MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology. The purpose of the laboratory evaluation was to establish the performance of the leukocyte and specific gravity tests and to evaluate the pH, nitrite and blood for placement adjacent to these tests on the DIASCREEN® Reagent Strip for Urinalysis when compared to a "510 (k) approved" marketed urinalysis strip svstem.
The study consisted of comparing the performance of two (2) manufactured lots of DIASCREEN® Reagent Strips with the marketed product (Bayer Multistix 10 SG).
Fresh urine samples were obtained at the medical facility. The comparison strips. Baver Multistix 10 SG Reagent Strips, Schein Urispec Reagent Strips(for ascorbic acid detection), Boehringer Manneheim Corporation CHEMSTRIP Reagent Strips(for confirmatory testing), normal and abnormal urine controls were furnished by Dia-Screen. When data between the two products did not agree within one color block, an alternate procedure (see table below) was used to test the sample.
| Analyte | Confirmation Test | Manufacturer |
|---|---|---|
| Specific Gravity | Refractometer | NA |
| Leukocyte | Microscopic EvaluationCHEMSTRIP | NABoehringer Mannheim |
| pH | pH Meter | NA |
| Blood | Microscopic EvaluationCHEMSTRIPAscorbic Acid Test/Urispec | NABoehringer MannheimHenry Schein |
| Nitrite | Microscopic EvaluationCHEMSTRIP | NABoehringer Mannheim |
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Fresh, well-mixed, and uncentrifuged urine from a mixed patient population was reacted with the DIASCREEN® Reagent Strips and the results were read by visual comparison with the DIASCREEN® color chart. Results of these readings were compared to results measured by Multistix 10 SG Reagent Strips.
A summary of the data obtained from the clinical evaluation described above is provided in the following tables.
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DIASCREEN® versus Bayer Clinical Correlation
Tables I and II present the percentage of responses for the indicated lots of the DIASCREEN® and Bayer Reagent Strips that are within the same color block and that are within plus or minus one color block. Table III presents a similar analysis for the two lots of the DIASCREEN® Reagent Strips.
DIASCREEN® Lot 1 versus Bayer Lot D639066 or 6K30C Table I.
| Same Color Block | ||
|---|---|---|
| Specific Gravity | 39/53 | 74% |
| Leukocyte | 42/53 | 79% |
| pH | 37/53 | 70% |
| Blood | 49/53 | 92% |
| Nitrite | 53/53 | 100% |
| Within 1 Color Block | |
|---|---|
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
DIASCREEN® Lot 2 versus Bayer Lot D639066 or 6K30C Table II.
| Same Color Block | ||
|---|---|---|
| Specific Gravity | 35/53 | 66% |
| Leukocyte | 43/53 | 81% |
| pH | 35/53 | 66% |
| Blood | 44/53 | 83% |
| Nitrite | 53/53 | 100% |
| Within 1 Color Block | |
|---|---|
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
DIASCREEN® Lot 1 versus DIASCREEN® Lot 2 Table III.
| Same Color Block | ||
|---|---|---|
| Specific Gravity | 48/53 | 91% |
| Leukocyte | 47/53 | 89% |
| pH | 49/53 | 92% |
| Blood | 52/53 | 98% |
| Nitrite | 53/53 | 100% |
| Within 1 Color Block | |
|---|---|
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
| 53/53 | 100% |
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Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black against a white background. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 17 1997
John Murray President and Chief Executive Officer Dia-Screen Corporation -----5182 West 76th Street Minneapolis, Minnesota ਦ ਦੇ ਕੇ ਤੇ ਰ
K971976 Re : DIASCREEN® 10 Way Reagent Strips for Urinalysis (In Duplicate) Regulatory Class: I & II Product Code: LJX, JNA, KQO May 27, 1997 Dated: Received: May 29, 1997
Dear Mr. Murray:
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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP 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 requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (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 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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 its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 0(k) Number (if known): | K971976 |
|---|---|
| Device Name: | DIASCREEN Reagent Strips |
| Indications For Use: |
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip
and is intended for use as an in vitro diagnostic aid using urine specimens.
The strip contains solid phase reagent areas affixed to a plastic strip and is
provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity,
ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and
urobilinogen by visual comparison with a color chart for each concentration
range. No additional reagents and laboratory equipment are required. The
reagent strips are packaged in a plastic vial containing a desiccant. The
test strips must be kept tightly capped in the vial to assure reagent
reactivity. The directions must be followed exactly and it is necessary to use
fresh, well-mixed, uncentrifuged urine for optimal results.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Page 1 of 1
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Veronica Calvin for Di Montgomery | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971976 |
| Prescription Use(21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| -------------------------------------- | ---- | -------------------------------------------------- |
.
:
・・
...
§ 864.7675 Leukocyte peroxidase test.
(a)
Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.