(43 days)
Not Found
No
The summary describes chemical reagents and a validator set for quantitative determination of enzyme activity, which are standard laboratory consumables and do not inherently involve AI/ML. The performance studies focus on method comparison and imprecision, typical for reagent validation, and there is no mention of AI, ML, or related concepts.
No
This device is an in vitro diagnostic (IVD) reagent system used for the quantitative determination of enzyme activity in human samples, which falls under diagnostic purposes rather than therapy.
Yes
The "Intended Use / Indications for Use" section states that the reagents are "intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma," "quantitative determination of pseudo-cholinesterase activity in human serum or plasma," "quantitative determination of γ-glutamyl transferase activity in human serum or plasma," and "quantitative determination of lactate dehydrogenase activity in human serum or plasma." These quantitative determinations of analytes in human samples are used for diagnosing or monitoring conditions.
No
The device description clearly states that the device is a "Reagent" and a "Validator Set," which are physical components used in laboratory testing, not software. The performance studies also describe method comparison and imprecision experiments related to these physical reagents.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the reagents are for the "quantitative determination of alkaline phosphatase activity in human serum or plasma," "quantitative determination of pseudo-cholinesterase activity in human serum or plasma," "quantitative determination of y-glutamyl transferase activity in human serum or plasma," and "quantitative determination of lactate dehydrogenase activity in human serum or plasma." These are all measurements performed in vitro (outside the body) on human specimens (serum or plasma) to provide information for diagnostic purposes.
- Device Description: The device description confirms these are "reagents" intended for use on "SYNCHRON Clinical Systems," which are laboratory instruments used for clinical testing.
- Performance Studies: The performance studies describe method comparison and imprecision experiments, which are standard types of studies conducted for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The listing of predicate devices with K numbers (K881498, K893583, K951964) indicates that these products have gone through the FDA clearance process for IVD devices.
The core function of these reagents and the validator set is to perform tests on human biological samples in vitro to measure specific enzyme activities, which is a defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems y- Glutamyl Transferase (GGT) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of yglutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems Lactate Dehydrogenase (L.D) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of lactate dehydrogenase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
Product codes (comma separated list FDA assigned to the subject device)
CJE, DIH, JPZ, CFJ, JIX
Device Description
The SYNCHRON Systems ALP. CHE, GGT, and LD Reagents are intended for use on Beckman's SYNCHRON Clinical Systems. These reagents may be used in conjunction with the SYNCHRON Enzyme Validator for assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the noncalibrated SYNCHRON Systems Enzyme Reagents and the calibrated SYNCHRON Systems Enzyme Reagents with the associated SYNCHRON Enzyme Validator.
Method Comparison Study Results:
SYNCHRON LX System Calibrated (DGKCH) ALP Reagent vs SYNCHRON LX System Uncalibrated ALP Reagent: Slope 1.426, Intercept 3.34, r 0.999, n 67
SYNCHRON LX System Calibrated (IFCC) ALP Reagent vs SYNCHRON LX System Uncalibrated ALP Reagent: Slope 1.019, Intercept -1.95, r 0.999, n 79
SYNCHRON LX System Calibrated CHE Reagent vs SYNCHRON LX System Uncalibrated CHE Reagent: Slope 0.760, Intercept 2.56, r 0.999, n 72
SYNCHRON LX System Calibrated GGT Reagent vs SYNCHRON LX System Uncalibrated GGT Reagen: Slope 1.141, Intercept -2.18, r 0.999, n 79
SYNCHRON LX System Calibrated LD Reagent vs SYNCHRON LX System Uncalibrated LD Reagent: Slope 1.242, Intercept -0.20, r 0.996, n 70
Estimated Imprecision (N=80 for all samples):
SYNCHRON LX Systems ALP Reagent:
Level 1: Mean 39.6 IU/L, Within-Run S.D. 1.77 IU/L (4.49%C.V.), Total S.D. 2.24 IU/L (5.66%C.V.)
Level 2: Mean 147.9 IU/L, Within-Run S.D. 2.68 IU/L (1.81%C.V.), Total S.D. 3.10 IU/L (2.10%C.V.)
Level 3: Mean 258.1 IU/L, Within-Run S.D. 1.92 IU/L (0.75%C.V.), Total S.D. 2.85 IU/L (1.10%C.V.)
SYNCHRON LX Systems CHE Reagent:
Level 1: Mean 2473 U/L, Within-Run S.D. 35.1 U/L (1.3%C.V.), Total S.D. 46.9 U/L (1.9%C.V.)
Level 2: Mean 3330 U/L, Within-Run S.D. 31.9 U/L (1.0%C.V.), Total S.D. 49.2 U/L (1.5%C.V.)
Level 3: Mean 8805 U/L, Within-Run S.D. 85.5 U/L (1.0%C.V.), Total S.D. 157.9 U/L (1.8%C.V.)
SYNCHRON LX Systems GGT Reagent:
Level 1: Mean 13.0 IU/L, Within-Run S.D. 1.72 IU/L (13.23%C.V.), Total S.D. 2.08 IU/L (16.01%C.V.)
Level 2: Mean 194.0 IU/L, Within-Run S.D. 1.84 IU/L (0.95%C.V.), Total S.D. 4.25 IU/L (2.19%C.V.)
Level 3: Mean 371.7 IU/L, Within-Run S.D. 1.56 IU/L (0.42%C.V.), Total S.D. 7.90 IU/L (2.13%C.V.)
SYNCHRON LX Systems LD Reagent:
Level 1: Mean 62.5 IU/L, Within-Run S.D. 2.2 IU/L (3.5%C.V.), Total S.D. 2.8 IU/L (4.5%C.V.)
Level 2: Mean 419.0 IU/L, Within-Run S.D. 3.5 IU/L (0.8%C.V.), Total S.D. 5.3 IU/L (1.3%C.V.)
Stability Study Results:
SYNCHRON Enzyme Validator: 18 month shelf-life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
MAY 23 1997
Summary of Safety & Effectiveness SYNCHRON Systems Enzyme Reagents and Enzyme Validator
1.0 Submitted By:
Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457
2.0 Date Submitted:
8 May 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Alkaline Phosphatase (ALP) Reagent SYNCHRON® Systems Cholinesterase (CHE) Reagent SYNCHRON® Systems y-Glutamyl Transferase (GGT) Reagent SYNCHRON® Systems Lactate Dehydrogenase (LD) Reagent SYNCHRON® Enzyme Validator Set
3.2 Classification Name
Alkaline Phosphatase or isoenzymes test system (21 CFR § 862.1050) Cholinesterase test system (21 CFR § 862.3240) Gamma-glutamyl transpeptidase and isoenzymes test system (21 CFR § 862.1360) Lactate Dehydrogenase test system (21 CFR § 862.1440) Calibrator (21 CFR § 862.1150)
enz_510k.sse
1
4.0 Predicate Device(s):
| SYNCHRON Reagent | Predicate | Predicate Company | Docket
Number |
|----------------------------------------------------------------|----------------------------------------------------------------|-----------------------------|------------------|
| SYNCHRON Systems
Alkaline Phosphatase
(ALP) Reagent | SYNCHRON Systems
Alkaline Phosphatase
(ALP) Reagent | Beckman Instruments
Inc. | K881498 |
| SYNCHRON Systems
Cholinesterase (CHE)
Reagent | SYNCHRON Systems
Cholinesterase (CHE)
Reagent | Beckman Instruments
Inc. | K893583 |
| SYNCHRON Systems
y-Glutamyl
Transferase (GGT)
Reagent | SYNCHRON Systems
y-Glutamyl
Transferase (GGT)
Reagent | Beckman Instruments
Inc. | K881498 |
| SYNCHRON Systems
Lactate
Dehydrogenase (LD)
Reagent | SYNCHRON Systems
Lactate
Dehydrogenase (LD)
Reagent | Beckman Instruments
Inc. | K881498 |
| SYNCHRON Enzyme
Validator Set | SYNCHRON Enzyme
Validator Set | Beckman Instruments
Inc. | K951964 |
and the comments of the first
:
2
.
2
5.0 Description:
The SYNCHRON Systems ALP. CHE, GGT, and LD Reagents are intended for use on Beckman's SYNCHRON Clinical Systems. These reagents may be used in conjunction with the SYNCHRON Enzyme Validator for assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
6.0 Intended Use:
The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems ~- Glutamyl Transferase (GGT) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of yglutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Systems Lactate Dehydrogenase (L.D) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of lactate dehydrogenase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
The SYNCHRON Enzyme Validator Set, in conjunction with specified enzyme assays on Beckman SYNCHRON Systems, is intended to provide points of reference in the measurement of selected human enzymes. Use of this product will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
3
Beckman Instruments, Inc., Section 510(k) Notification Beckman Instruments, The Reagents and Enzyme Validator Summary of Safety & Effectiveness
Comparison to Predicate(s): 7.0
The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON Systems | ||
| Enzyme Reagents | ||
| (ALP, CHE, GGT, LD) | Intended use | Same as the predicates |
| SYNCHRON Systems | ||
| Enzyme Reagents | ||
| (ALP, CHE, GGT, LD) | Chemical Reaction | Same principle as the predicates |
| SYNCHRON Systems | ||
| Enzyme Reagents | ||
| (ALP, CHE, GGT, LD) | Reagent Formulation | Same formulations as the predicates |
| SYNCHRON Systems | ||
| Enzyme Reagents | ||
| (ALP, CHE, GGT, LD) | Stability | Same as the predicates |
| SYNCHRON Systems | ||
| Enzyme Reagents | ||
| (ALP, CHE, GGT, LD) | Interferences | Same as the predicates |
| SYNCHRON Systems | ||
| Enzyme Reagents | ||
| (ALP, CHE, GGT, LD) | Anti-Coagulants | Same as the predicates |
| SYNCHRON Systems | ||
| Enzyme Reagents | ||
| (ALP, CHE, GGT, LD) | Packaging | Same as the predicates |
| SYNCHRON | ||
| Enzyme Validator | ||
| Set | Intended use | Same as the predicate |
| SYNCHRON | ||
| Enzyme Validator | ||
| Set | Formulation | Same formulation as predicate |
| SYNCHRON | ||
| Enzyme Validator | ||
| Set | Stability | Same as the predicate |
| SYNCHRON | ||
| Enzyme Validator | ||
| Set | Packaging | Same as the predicate |
SIMILARITIES to the PREDICATE
file: enz_510k.sse
4
4
| DIFFERENCES from the PREDICATE | ||
|---|---|---|
| Reagent | Aspect/Characteristic | Comments |
| SYNCHRON Systems | ||
| reagents (ALP, CHE, | ||
| GGT, LD,) | Calibration | ALP, CHE, GGT, LD are |
| calibrated with Enzyme Validator | ||
| product and the predicate | ||
| reagents are not | ||
| Standardization to | ||
| IFCC/DGKCh methods | When ALP, CHE, GGT, LD | |
| reagents are calibrated with | ||
| Enzyme Validator, the assay | ||
| results are standardized to | ||
| compatible IFCC/DGKCh | ||
| methods while assay results from | ||
| the predicate reagents are not | ||
| Reference Ranges | ALP, CHE, GGT, and LD | |
| reference ranges may differ from | ||
| the predicates | ||
| SYNCHRON Enzyme | ||
| Validator Set | Value Assignment | SYNCHRON Enzyme Validator in |
| addition to ALT-, AST- CK-, now | ||
| includes value assignments for | ||
| ALP, CHE, GGT, and LD assays | ||
| and the predicate Enzyme | ||
| Validator only has value | ||
| assignments for the ALT-, AST- | ||
| and CK- assays. |
DICCOCNCC fo שד איינומטמט 4-8
.
5
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the noncalibrated SYNCHRON Systems Enzyme Reagents and the calibrated SYNCHRON Systems Enzyme Reagents with the associated SYNCHRON Enzyme Validator.
| Reagent | Slope | Intercept | r | n | Predicate
Method |
|---------------------------------------------------------------|-------|-----------|-------|----|------------------------------------------------------|
| SYNCHRON
LX System
Calibrated
(DGKCH) ALP
Reagent | 1.426 | 3.34 | 0.999 | 67 | SYNCHRON
LX System
Uncalibrated
ALP Reagent |
| SYNCHRON
LX System
Calibrated
(IFCC) ALP
Reagent | 1.019 | -1.95 | 0.999 | 79 | SYNCHRON
LX System
Uncalibrated
ALP Reagent |
| SYNCHRON
LX System
Calibrated
CHE Reagent | 0.760 | 2.56 | 0.999 | 72 | SYNCHRON
LX System
Uncalibrated
CHE Reagent |
| SYNCHRON
LX System
Calibrated
GGT Reagent | 1.141 | -2.18 | 0.999 | 79 | SYNCHRON
LX System
Uncalibrated
GGT Reagent |
| SYNCHRON
LX System
Calibrated LD
Reagent | 1.242 | -0.20 | 0.996 | 70 | SYNCHRON
LX System
Uncalibrated
LD Reagent |
Method Comparison Study Results SYNCHRON Systems ALP, CHE, GGT, LD Reagents
Estimated Imprecision
SYNCHRON LX Systems ALP Reagent
| Sample | Mean (IU/L) | S.D. (IU/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 39.6 | 1.77 | 4.49 | 80 |
| Level 2 | 147.9 | 2.68 | 1.81 | 80 |
| Level 3 | 258.1 | 1.92 | 0.75 | 80 |
| Total Imprecision | ||||
| Level 1 | 39.6 | 2.24 | 5.66 | 80 |
| Level 2 | 147.9 | 3.10 | 2.10 | 80 |
| Level 3 | 258.1 | 2.85 | 1.10 | 80 |
6
SYNCHRON LX Systems CHE Reagent
| Sample | Mean (U/L) | S.D. (U/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 2473 | 35.1 | 1.3 | 80 |
| Level 2 | 3330 | 31.9 | 1.0 | 80 |
| Level 3 | 8805 | 85.5 | 1.0 | 80 |
| Total Imprecision | ||||
| Level 1 | 2473 | 46.9 | 1.9 | 80 |
| Level 2 | 3330 | 49.2 | 1.5 | 80 |
| Level 3 | 8805 | 157.9 | 1.8 | 80 |
SYNCHRON LX Systems GGT Reagent
| Sample | Mean (IU/L) | S.D. (IU/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 13.0 | 1.72 | 13.23 | 80 |
| Level 2 | 194.0 | 1.84 | 0.95 | 80 |
| Level 3 | 371.7 | 1.56 | 0.42 | 80 |
| Total Imprecision | ||||
| Level 1 | 13.0 | 2.08 | 16.01 | 80 |
| Level 2 | 194.0 | 4.25 | 2.19 | 80 |
| Level 3 | 371.7 | 7.90 | 2.13 | 80 |
SYNCHRON LX Systems LD Reagent
| Sample | Mean (IU/L) | S.D. (IU/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 62.5 | 2.2 | 3.5 | 80 |
| Level 2 | 419.0 | 3.5 | 0.8 | 80 |
| Total Imprecision | ||||
| Level 1 | 62.5 | 2.8 | 4.5 | 80 |
| Level 2 | 419.0 | 5.3 | 1.3 | 80 |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| SYNCHRON Enzyme Validator | 18 month shelf-life |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
file: enz_510k.sse
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with stylized wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 3 1997
Lucinda Stockert · Senior Requlatory Specialist Beckman Instruments, Inc. --200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 Brea, California 92822-8000
Re: K971333 SYNCHRON® Systems Enzyme Reagents and Enzyme Validator Regulatory Class: I & II Product Code: CJE, DIH, JPZ, CFJ, JIX Dated: March 28, 1996 Received: April 1, 1996
Dear Ms. Stockert:
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 requlations 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 regulations.
8
Page 2
SE III E START FOR
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHA-607) Chird device 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 described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed produce, 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 compreation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entified, "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 obtained 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
9
510(k) Number (if known):
SYNCHRON® Systems Alkaline Phosphatase (ALP) Device Name: Reagent
Indications for Use:
The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
21 CFR 862.1050 Alkaline Phosphatase or isoenzymes test system.
(a) Identification. An alkaline phosphatase system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
(b) Classification. Class II.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971333 |
| Prescription Use | ✓ | OR | Over-the-Counter Use ______ |
|---|---|---|---|
| (per 21 CFR 801.109) | Optional Format 1-2-96 |
10
page of
510(k) Number (if known):
SYNCHRON® Systems Cholinesterase (CHE) Reagent Device Name:
Indications for Use:
The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
21 CFR 862.3240 Cholinesterase test system.
(a) Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetyl-choline to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinvicholine poisoning).
(b) Classification. Class I
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96
11
510(k) Number (if known):
SYNCHRON Systems y-Glutamyl Transferase Reagent Device Name:
Indications for Use:
SYNCHRON Systems y-Glutamyl Transferase (GGT) Reagent, The in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of y-glutamyl transferase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in coniunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) and the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
21 CFR 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
(a) Identification. A gamma-glutamy) transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gammaqlutamy] transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic circhosis and primary and secondary liver tumors.
(b) Classification. Class I.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96
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510(k) Number (if known):
Device Name:
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SYNCHRON® Systems Alkaline Phosphatase (ALP) Reagent
Indications for Use:
The SYNCHRON Systems Alkaline Phosphatase (ALP) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of alkaline phosphatase activity in human serum or plasma on SYNCHRON Systems. Use of this product, in conjunction with the SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the International Federation of Clinical Chemistry (IFCC) or the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
21 CFR 862.1050 Alkaline Phosphatase or isoenzymes test system.
(a) Identification. An alkaline phosphatase system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
(b) Classification. Class II.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | c971333 |
|---|---|
| --------------- | --------- |
| Prescription Use (per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-the-Counter Use Optional Format 1-2-96 | |
|---|---|
| --------------------------------------------- | -- |
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page of of
510(k) Number (if known):
SYNCHRON® Systems Cholinesterase (CHE) Reagent Device Name:
Indications for Use:
and and the specifical and the
The SYNCHRON Systems Cholinesterase (CHE) Reagent, in conjunction with SYNCHRON Enzyme Validator Set, is intended for the quantitative determination of pseudo-cholinesterase activity in human serum or plasma on Use of this product, in conjunction with the SYNCHRON Systems. SYNCHRON Enzyme Validator Set, will result in assay values which are compatible with those from methods recommended by the German Society for Clinical Chemistry (Deutsche Gesellschaft fur Klinische Chemie, DGKCh).
21 CFR 862.3240 Cholinesterase test system.
(a) Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetyl-choline to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).
(b) Classification. Class I
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﺮ (per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96