(17 days)
AUH1011, AUH1012, AUH1013, AUH1014, AUH1015, AUH1016, AUH1018
Not Found
No
The summary describes in vitro diagnostic reagents for use with existing chemistry systems and does not mention any AI or ML components. The performance studies focus on standard analytical metrics like precision and correlation.
No.
The device is described as an in vitro diagnostic solution for quantitative determination of Na+, K+, and Cl- on Olympus Chemistry Systems, which are clinical chemistry tests. It is not intended for direct therapeutic use.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The products encompassed by this request are intended for in vitro diagnostic use and the quantitative determination of Na", K", and Cl ", on the Olympus Chemistry Systems." This directly indicates its function as a diagnostic device. The products are described as "In Vitro Diagnostic Solutions" in the "Device Description" section.
No
The device described is a set of In Vitro Diagnostic Solutions (reagents) intended for use with a chemistry analyzer. These are physical chemical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The products encompassed by this request are intended for in vitro diagnostic use..."
- Purpose: The products are intended for the "quantitative determination of Na", K", and Cl" in serum and urine. This is a diagnostic measurement performed on biological samples outside of the body.
- Use with IVD System: The reagents are designed to be used with the Olympus Chemistry Systems, which are described as performing "a broad array of clinical chemistry tests." Clinical chemistry tests are a core component of in vitro diagnostics.
- Regulatory Classification: The "Device Description" section states the products are "Class II (75JIX) In Vitro Diagnostic Solutions." The classification itself confirms its IVD status.
The entire description aligns with the definition and purpose of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The products encompassed by this request are intended for in vitro diagnostic use and the quantitative determination of Na", K", and Cl ", on the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the chemistry systems and of the predicate Reagents. The Olympus Chemistry Systems performs a broad array of clinical chemistry tests. The Olympus Chemistry Systems with the ISE module measures sodium (Na), potassium (K), and chloride (Cl ) by Ion Selective Electrodes. These Reagents are intended to be used with the equivalent Olympus Chemistry Systems. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Olympus .
The Buffer dilutes all measured samples for the quantitative determinations in Na ", K , and Cl in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na , K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na ", K", and Cl " electrodes on the Olympus Chemistry System. The Serum High/Low Standard and Urine High/Low Standard are used to calibrate the Na *, K , and Cl clectrodes of the system's ISE module. The ISE Na "/K " Selectivity Na 7, KT, electrode verification. The products Check Solutions are intended for encompassed are to be handled using normal laboratory precautions.
Product codes (comma separated list FDA assigned to the subject device)
CGZ, JGS, CEM
Device Description
The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The ISE Reagents are intended for use on the ISE module of the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the system and of predicate ISE Reagents which are necessary for the continued operation and use of the ISE module on these systems.
Information herein will support ALKO's position for the intended use of these products to the Olympus Chemistry System with the ISE module. The ISE module measures Na , K , Cl by using the system's Ion Selective Electrodes. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Olympus America Incorporated. The Buffer dilutes all measured samples for the quantitative determinations of Na , K , and Cl concentrations in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift. in the quantitative determination of Na K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na , K , and Cl electrodes on the Olympus Chemistry Systems. The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module. The ISE Na /K Selectivity Check Solutions are intended for Na and K electrode verification.
ALKO product A101-100 (ISE Buffer) is equivalent to Olympus Chemistry System product AUH1011 (ISE Buffer). ALKO Product A101-200 (ISE Mid - Standard Solution) is equivalent to Olympus Chemistry System product AUH1012 (ISE Mid-Standard). ALKO product A101-300 (ISE Reference Solution) is equivalent to Olympus Chemistry System product AUH1013 (ISE Reference Solution). ALKO product A101-400 (ISE Low Serum Standard) is equivalent to Olympus Chemistry System product AUH1014 (ISE Low Serum Standard). ALKO product A101-500 (ISE High Serum Standard) is equivalent to Olympus Chemistry System product AUH1015 (ISE High Serum Standard). ALKO product A101-600 (ISE High/Low Urine Standard) is equivalent to Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard), ALKO product A101-800 (Na7 K Selectivity Check Solution) is equivalent to Olympus Chemisty System product AUH1018 ((Na / K+ Selectivity Check Solution).
ALKO uses a similar composition, description and packaging design as that used by Olympus America in its products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
ALKO has shown performance equivalence of its products to Olympus America products in the following manner:
- Through a method comparison where results obtained on an equivalent Olympus Chemistry System, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Olympus products; and
- Through a precision study where ALKO products were installed on an equivalent Olympus Chemistry System and samples were measured over 20 runs.
Precision Data:
Precision data was collected from the analysis of three levels of serum controls and two levels of urine controls, measured in duplicate per run, four runs per day for at least five days on the ISE Module of the Olympus AU800 analyzer for Na /K+/Cl , calibrated with all ALKO reagents.
Serum Level 1:
Na+: N=48 (Total), Mean=127, STD=0.7535, CV%=0.5939; N=24 (W-Run), Mean=127, STD=0.8165, CV%=0.6435
K+: N=48 (Total), Mean=3.2, STD=0.0143, CV%=0.4466; N=24 (W-Run), Mean=3.2, STD=0.0204, CV%=0.6383
Cl-: N=48 (Total), Mean=83, STD=0.6641, CV%=0.7993; N=24 (W-Run), Mean=83, STD=0.5774, CV%=0.6977
Serum Level 2:
Na+: N=48 (Total), Mean=139, STD=0.8777, CV%=0.6314; N=24 (W-Run), Mean=139, STD=0.9789, CV%=0.7042
K+: N=48 (Total), Mean=4.5, STD=0.0534, CV%=1.1749; N=24 (W-Run), Mean=4.5, STD=0.0408, CV%=0.8989
Cl-: N=48 (Total), Mean=83, STD=0.6641, CV%=0.7993; N=24 (W-Run), Mean=83, STD=0.5774, CV%=0.6977
Serum Level 3:
Na+: N=48 (Total), Mean=156, STD=0.8268, CV%=0.5302; N=24 (W-Run), Mean=156, STD=0.7360, CV%=0.4720
K+: N=48 (Total), Mean=5.9, STD=0.0729, CV%=1.2266; N=24 (W-Run), Mean=5.9, STD=0.0791, CV%=1.3310
Cl-: N=48 (Total), Mean=114, STD=0.9270, CV%=0.8159; N=24 (W-Run), Mean=114, STD=0.7638, CV%=0.6722
Urine Level 1:
Na+: N=48 (Total), Mean=58, STD=0.5770, CV%=0.9866; N=24 (W-Run), Mean=58, STD=0.7906, CV%=1.3519
K+: N=48 (Total), Mean=23.4, STD=0.1887, CV%=0.8065; N=24 (W-Run), Mean=23.4, STD=0.1568, CV%=0.6700
Cl-: N=48 (Total), Mean=58, STD=0.4560, CV%=0.7881; N=24 (W-Run), Mean=58, STD=0.5401, CV%=0.9335
Urine Level 2:
Na+: N=48 (Total), Mean=184, STD=1.2741, CV%=0.6942; N=24 (W-Run), Mean=184, STD=1.0801, CV%=0.5885
K+: N=48 (Total), Mean=130.6, STD=0.9643, CV%=0.7383; N=24 (W-Run), Mean=130.6, STD=0.7277, CV%=0.5572
Cl-: N=48 (Total), Mean=288, STD=2.3629, CV%=0.8219; N=24 (W-Run), Mean=288, STD=1.6583, CV%=0.5768
Correlation with Olympus Reagents (Linear Regression Analyses):
Serum Samples: 40 serum samples and 9 serum controls for Na, K, Cl (N=49)
Na: Slope=1.0242, Intercept=-3.4021, R Sq.=0.9995, Range=65-183
K: Slope=0.9900, Intercept=0.0242, R Sq.=0.9998, Range=1.4-10.9
Cl: Slope=0.9892, Intercept=-0.6464, R Sq.=0.9997, Range=37-165
Urine Samples: 70 urine samples and 6 urine controls for Na/Cl (N=76); 66 urine samples and 6 urine controls for K (N=72)
Na: Slope=1.0191, Intercept=-1.0199, R Sq.=0.9991, Range=13-361
K: Slope=1.0325, Intercept=-1.0404, R Sq.=0.9997, Range=5.7-306.0
Cl: Slope=1.0016, Intercept=0.4077, R Sq.=0.9993, Range=13-452
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.
0
510(k) Summary for ALKO Reagents on the ISE Module of the Olympus AU 800™ /AU 5200TM JUN 1 6 1997 Chemistry Systems
The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The ISE Reagents are intended for use on the ISE module of the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the system and of predicate ISE Reagents which are necessary for the continued operation and use of the ISE module on these systems.
Information herein will support ALKO's position for the intended use of these products to the Olympus Chemistry System with the ISE module. The ISE module measures Na , K , Cl by using the system's Ion Selective Electrodes. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Olympus America Incorporated. The Buffer dilutes all measured samples for the quantitative determinations of Na , K , and Cl concentrations in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift. in the quantitative determination of Na K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na , K , and Cl electrodes on the Olympus Chemistry Systems. The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module. The ISE Na /K Selectivity Check Solutions are intended for Na and K electrode verification.
ALKO product A101-100 (ISE Buffer) is equivalent to Olympus Chemistry System product AUH1011 (ISE Buffer). ALKO Product A101-200 (ISE Mid - Standard Solution) is equivalent to Olympus Chemistry System product AUH1012 (ISE Mid-Standard). ALKO product A101-300 (ISE Reference Solution) is equivalent to Olympus Chemistry System product AUH1013 (ISE Reference Solution). ALKO product A101-400 (ISE Low Serum Standard) is equivalent to Olympus Chemistry System product AUH1014 (ISE Low Serum Standard). ALKO product A101-500 (ISE High Serum Standard) is equivalent to Olympus Chemistry System product AUH1015 (ISE High Serum Standard). ALKO product A101-600 (ISE High/Low Urine Standard) is equivalent to Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard), ALKO product A101-800 (Na7 K Selectivity Check Solution) is equivalent to Olympus Chemisty System product AUH1018 ((Na / K+ Selectivity Check Solution).
ALKO uses a similar composition, description and packaging design as that used by Olympus America in its products. ALKO has shown performance equivalence of its products to Olympus America products in the following manner:
- O Through a method comparison where results obtained on an equivalent Olympus Chemistry System, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Olympus products; and
- O Through a precision study where ALKO products were installed on an equivalent Olympus Chemistry System and samples were measured over 20 runs. A summary of the results of these studies follows:
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Page 2 / ALKO 510(k) Summary for ISE Olympus Reagents.
PERFORMANCE CHARACTERISTICS
Precision Data
Precision data was collected from the analysis of three levels of serum controls and two levels of urine controls, measured in duplicate per run, four runs per day for at least five days on the ISE Module of the Olympus AU800 analyzer for Na /K+/Cl , calibrated with all ALKO reagents.
Serum Level 1
| N | Mean | STD | CV% | |
|---|---|---|---|---|
| Na+ | Total 48 | 127 | 0.7535 | 0.5939 |
| W-Run 24 | 127 | 0.8165 | 0.6435 | |
| K+ | Total 48 | 3.2 | 0.0143 | 0.4466 |
| W-Run 24 | 3.2 | 0.0204 | 0.6383 | |
| Cl- | Total 48 | 83 | 0.6641 | 0.7993 |
| W-Run 24 | 83 | 0.5774 | 0.6977 |
Serum Level 2
| . Mean | I STD STD I STD STORE I STORE I STORES STATE STORES STATE STATE STATE STATE STATE STATE STATE STATE STATE STATE STATE ASSESS FOR STATE ASSESS FOR STATE ASSESS FOR AND STATES | CV% - | |||
|---|---|---|---|---|---|
| Total | 48 | 139 | 0.8777 | 0.6314 | |
| W-Run | 24 | 139 | 0.9789 | 0.7042 | |
| Total | 48 | 4.5 | 0.0534 | 1.1749 | |
| W-Run | 24 | 4.5 | 0.0408 | 0.8989 | |
| Crisi | Total | 48 | 83 | 0.6641 | 0.7993 |
| W-Run | 24 | 83 | 0.5774 | ﺔ 0.6977 |
Serum Level 3
| N | Mean | STD | CV% | ||
|---|---|---|---|---|---|
| Na+ | Total | 48 | 156 | 0.8268 | 0.5302 |
| W-Run | 24 | 156 | 0.7360 | 0.4720 | |
| K+ | Total | 48 | 5.9 | 0.0729 | 1.2266 |
| W-Run | 24 | 5.9 | 0.0791 | 1.3310 | |
| Cl- | Total | 48 | 114 | 0.9270 | 0.8159 |
| W-Run | 24 | 114 | 0.7638 | 0.6722 |
2
Urine Level 1
| N | Mean | STD | CV% | ||
|---|---|---|---|---|---|
| Na+ | Total | 48 | 58 | 0.5770 | 0.9866 |
| W-Run | 24 | 58 | 0.7906 | 1.3519 | |
| K+ | Total | 48 | 23.4 | 0.1887 | 0.8065 |
| W-Run | 24 | 23.4 | 0.1568 | 0.6700 | |
| Cl- | Total | 48 | 58 | 0.4560 | 0.7881 |
| W-Run | 24 | 58 | 0.5401 | 0.9335 |
Urine Level 2
| N | Mean | STD | CV% | ||
|---|---|---|---|---|---|
| Na $+$ | Total | 48 | 184 | 1.2741 | 0.6942 |
| W-Run | 24 | 184 | 1.0801 | 0.5885 | |
| K $+$ | Total | 48 | 130.6 | 0.9643 | 0.7383 |
| W-Run | 24 | 130.6 | 0.7277 | 0.5572 | |
| Cl $-$ | Total | 48 | 288 | 2.3629 | 0.8219 |
| W-Run | 24 | 288 | 1.6583 | 0.5768 |
Note: W-Run = Within Run
Correlation with Olympus Reagents
Linear Regression Analyses were performed using the Olympus data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX.
Serum Samples :
Correlation data were collected from 40 serum samples and 9 serum controls for Na 7K / C/C / measured on the ISE Module of the Olympus AU800 analyzer, calibrated with ALKO as compared with Olympus reagents separately.
| Na | K | Cl | |
|---|---|---|---|
| N | 49 | 49 | 49 |
| Slope | 1.0242 | 0.9900 | 0.9892 |
| Intercept | -3.4021 | 0.0242 | -0.6464 |
| R Sq.* | 0.9995 | 0.9998 | 0.9997 |
| Range | 65 - 183 | 1.4 - 10.9 | 37 - 165 |
3
. . Urine Samples:
Urine Samples:
Correlation data were collected from 70 urine samples and 6 urine controls for Na 7 CT, and 66 urine samples and 6 urine controls for K+, measured on the ISE Module of the Olympus AU800 analyzer, calibrated with ALKO as compared with Olympus reagents separately.
| Na | K | Cl | |
|---|---|---|---|
| N | 76 | 72 | 76 |
| Slope | 1.0191 | 1.0325 | 1.0016 |
| Intercept | -1.0199 | -1.0404 | 0.4077 |
| R Sq.* | 0.9991 | 0.9997 | 0.9993 |
| Range | 13 - 361 | 5.7 - 306.0 | 13 - 452 |
*R Sq = Correlation Coefficient Squared
I hope that you find this information useful and informative.
Janet McCurdy
Janet A.McGrath Regulatory Affairs
ರಿಗ ర న్నారు. విశ
(date prepared)
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes, creating a sense of movement and flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 6 1997
Janet A. McGrath Regulatory Affairs Specialist ALKO Diagnostics …………………………………… 333 Fiske Street Holliston, Massachusetts 01746
Re : K972004 ISE Reagents for Olympus AU 800™/AU 5200™ Chemistry Systems Requlatory Class: II Product Code: CGZ, JGS, CEM May 29, 1997 Dated: Received: May 30, 1997
Dear Ms. McGrath:
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, Druq, 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 requlation may result in requlatory 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.
5
Paqe 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.
在 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 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 Sitman
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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Page 1 of 1
510(k) Number (if known): K972004
Device Name: ISB Reagents on Equivalent Olymous Chemistry Systems
Indication For Use:
The products encompassed by this request are intended for in vitro diagnostic use and the quantitative determination of Na", K", and Cl ", on the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the chemistry systems and of the predicate Reagents. The Olympus Chemistry Systems performs a broad array of clinical chemistry tests. The Olympus Chemistry Systems with the ISE module measures sodium (Na), potassium (K), and chloride (Cl ) by Ion Selective Electrodes. These Reagents are intended to be used with the equivalent Olympus Chemistry Systems. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Olympus .
The Buffer dilutes all measured samples for the quantitative determinations in Na ", K , and Cl in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na , K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na ", K", and Cl " electrodes on the Olympus Chemistry System. The Serum High/Low Standard and Urine High/Low Standard are used to calibrate the Na *, K , and Cl clectrodes of the system's ISE module. The ISE Na "/K " Selectivity Na 7, KT, electrode verification. The products Check Solutions are intended for encompassed are to be handled using normal laboratory precautions.
(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 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)