HCL - 200 BIOCHEMISTRY ANALYZER
Device Facts
| Record ID | K964409 |
|---|---|
| Device Name | HCL - 200 BIOCHEMISTRY ANALYZER |
| Applicant | Hcl Laboratory Systems, Inc. |
| Product Code | JJF · Clinical Chemistry |
| Decision Date | Jan 22, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2170 |
| Device Class | Class 1 |
Intended Use
The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.
Device Story
HCL-200 is an automated discrete random access in vitro diagnostic multichannel chemistry analyzer. System comprises two modules: liquid handling (reagents, samples, pipetting unit) and reaction module (cuvette turntable, photometer). Device connects to a PC-compatible computer for software control. Operates as an automated interference filter photometer measuring radiant energy (absorbed or transmitted) at wavelengths 340-700 nm. Used in clinical laboratory settings by trained personnel to perform quantitative analysis of clinical chemistry analytes. Output consists of measured analyte concentrations, which assist healthcare providers in diagnosing and monitoring patient health status.
Clinical Evidence
Bench testing only. Performance evaluated using NCCLS protocols (EP5-T2, EP6-P, EP9-T, EP10-T2) comparing HCL-200 to Roche COBAS MIRA. Testing included linearity, simple precision (N=20), complex precision (N=80), and method comparison (N=100-400 samples per analyte). Results demonstrated strong correlation (r=0.983 to 0.999) and acceptable precision (CVs generally <10%) across 16 clinical chemistry analytes including Albumin, ALT, Amylase, AST, Bilirubin, BUN, CK, Creatinine, CRP, GGT, Glucose, LDH-L, Phosphorus, Total Protein, Triglycerides, and Uric Acid.
Technological Characteristics
Automated discrete random access multichannel chemistry analyzer. Sensing principle: interference filter photometry (340-700 nm). Components: liquid handling module, reaction module with cuvette turntable. Connectivity: PC-compatible computer interface. Software-controlled operation.
Indications for Use
Indicated for use as an in vitro diagnostic multichannel chemistry analyzer for clinical laboratory testing.
Regulatory Classification
Identification
A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
Predicate Devices
- COBAS MIRA (K851172)
Related Devices
- K112412 — AU5800(R) CHEMISTRY ANALYZER · Beckman Coulter, Inc. · Dec 23, 2011
- K072140 — S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 24, 2008
- K981743 — OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER · Olympus America, Inc. · Jun 9, 1998
- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK · Jas Diagnostics, Inc. · May 15, 2014
- K070704 — TRILOGY ANALYZER · Drew Scientific, Inc. · Jul 13, 2007
Submission Summary (Full Text)
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K964409
HCL Laboratory Systems, Inc. 510(k) Notification for HCL -200
JAN 22 1997
## 510 (k) Summary of Safety and Effectiveness
## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS OF THE HCL-200 CLINICAL CHEMISTRY ANALYZER:
### Submitted by:
Gregory M. Hearne
Executive Vice President
HCL Laboratory Systems Inc.
362 Camino Bailen
Escondido, CA 92029
Telephone: (619) 738 - 8371.
FAX: (619) 738 - 8371.
### Identification:
- Trade Name: HCL - 200 Biochemistry Analyzer.
- Common or usual name: Clinical Chemistry Analyzer
- Classification name: Micro Chemistry Analyzer for Clinical Use.
### Description:
The HCL-200 is an automated discrete random access in vitro diagnostic multichannel chemistry analyzer. It is composed of two modules:
- The liquid handling system includes compartments of reagents and samples as well as the pipetting unit.
- The reaction module includes the cuvette turntable to which samples and reagents are transferred. A photometer to monitor reaction response is also contained in this unit.
Then analyzer is linked to a PC compatible computer which loads software into each of the two modules.
### Intended Use:
The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.
### Technological Characteristics Compared to the Predicate Device
The functions of the HCL-200 and the COBAS MIRA [510 (k) K851172] are fundamentally the same. The basic physical principles for measurement of radiant energy, absorbed or transmitted, under controlled conditions are the same. Both instruments are automated interference filter photometers capable of measuring monochromatic light with wavelengths between 340 and 700 nm.
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HCL Laboratory Systems, Inc.
510(k) Notification for HCL -200
# Substantial Equivalence and Summary Performance Data:
NCCLS evaluation protocols were used to demonstrate substantially equivalent performance between the HCL-200 and the predicate device. NCCLS Documents used in the evaluation of HCL-200 and the comparison to the Roche COBAS MIRA are listed below:
| Table 3 NCCLS Protocols Used in Evaluation/ Comparison | |
| --- | --- |
| NCCLS Document Number | Document Title |
| EP 10 - T2
Vol. 13 No, 10 | Preliminary Evaluation of Quantitative Clinical Laboratory Methods, Second Edition |
| EP6-P
Vol. 6 No. 18 | Evaluation of the Linearity of Quantitative Analytical Methods |
| EP5 - T2
Vol. 12, No.4 | Evaluation of Precision Performance of Clinical Chemistry Devices, Second Edition |
| EP9 - T
Vol. 13 No. 4 | Method Comparison and Bias Estimation Using Patient Samples. |
Method protocols (applications) for OEM supplied reagents listed below were developed on the instrument after a two week device familiarization period as described in the NCCLS Documents. Preliminary evaluations using NCCLS EP 10 - T2 were run on each reagent in order to optimize application parameters.
| Table 4 OEM Supplied Reagents | | | |
| --- | --- | --- | --- |
| REAGENT NAME | 510k Number | REAGENT NAME | 510k Number |
| Albumin | K831585 | CRP | K902593 |
| ALT (GPT) | K820525 | GGT | K905085 |
| Amylase | K861718 | Glucose, Hexokinase
UV | K801765 |
| AST (GOT) | K820270 | LDH-L | K822312 |
| Bilirubin, Total | K841892 | Phosphorus | K870776 |
| BUN, Rate | K812417 | Total Protein | K841466 |
| CK NAD, Imidazole | K905084/A | Triglycerides GPO | K842029/A |
| Creatinine, (Jaffe) | K840872 | Uric Acid | K812641 |
A summary of pertinent statistical results are presented in the table on the following two (2) pages:
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HCL Laboratory Systems, Inc.
510(k) Notification for HCL -200
| Table 5 Performance Data Summary | | | | |
| --- | --- | --- | --- | --- |
| REAGENT NAME | LINEARITY | SIMPLE PRECISION | COMPLEX PRECISION | COMPARISON TO PREDICATE (COBAS MIRA) |
| Albumin | Number [N]: 5
Linear Range: 2 TO 8.5 g/dL | Number [N]: 20
Normal: CV: 1.8%
Abnormal CV: 1.7% | Number [N]: 80
Normal: CV: 8%
Abnormal CV: 6.4% | Number [N]: 100
Slope [m]: 1.000
Intercept [b]: -0.03
Correlation Coeff. [r]: 0.987 |
| ALT (GPT) | Number [N]: 7
Linear Range: 0 to 650 U/L | Number [N]:20
Normal: CV:3%
Abnormal CV:1.5% | Number [N]: 80
Normal: CV: 4.6%
Abnormal CV: 2.1% | Number [N]: 104
Slope [m]: 1.08
Intercept [b]: 0.6
Correlation Coeff. [r]: 0.998 |
| Amylase | Number [N]: 9
Linear Range: 0 to 2500 U/L | Number [N]: 20
Normal: CV: 4.6%
Abnormal CV: 1.7% | Number [N]: 80
Normal: CV: 5.0%
Abnormal CV: 3.5% | Number [N]: 101
Slope [m]: 1.09
Intercept [b]: -2.8
Correlation Coeff. [r]: 0.999 |
| AST (GOT) | Number [N]: 6
Linear Range: 0 to 650 U/L | Number [N]: 20
Normal: CV: 3.5%
Abnormal CV: 2.6% | Number [N]: 80
Normal: CV: 6.1%
Abnormal CV: 4.6% | Number [N]: 100
Slope [m]: 1.05
Intercept [b]: -.0.6
Correlation Coeff. [r]: 0.997 |
| Bilirubin, Total | Number [N]: 6
Linear Range: 0 to 20 mg/dL | Number [N]: 20
Normal: CV: 2.8%
Abnormal CV: 1.5% | Number [N]: 80
Normal: CV: 7.3%
Abnormal CV: 9.0% | Number [N]: 100
Slope [m]: 0.902
Intercept [b]: 0.11
Correlation Coeff. [r]: 0.993 |
| BUN, Rate | Number [N]: 5
Linear Range: 0 to 125mg/dL | Number [N]: 20
Normal: CV: 4.1%
Abnormal CV: 1.9% | Number [N]: 80
Normal: CV: 5.8%
Abnormal CV: 5.2% | Number [N]: 100
Slope [m]: 0.948
Intercept [b]: 1.1
Correlation Coeff. [r]: 0.996 |
| CK NAD, Imidazole | Number [N]: 8
Linear Range: 0 to 2100 U/L | Number [N]: 20
Normal: CV: 2.3%
Abnormal CV:2.3% | Number [N]: 80
Normal: CV: 4.6%
Abnormal CV: 2.1% | Number [N]: 100
Slope [m]: 1.034
Intercept [b]: 5.6
Correlation Coeff. [r]: 0.999 |
| Creatinine, (Jaffe) | Number [N]: 5
Linear Range: 0 to 12.5 mg/dL | Number [N]: 20
Normal: CV: 2.45%
Abnormal CV: 1.9% | Number [N]: 80
Normal: CV: 7.2%
Abnormal CV: 3.1% | Number [N]: 103
Slope [m]: 0.994
Intercept [b]: 0.045
Correlation Coeff. [r]: 0.997 |
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HCL Laboratory Systems, Inc.
510(k) Notification for HCL -200
| Table 5 Performance Data Summary, continued | | | | |
| --- | --- | --- | --- | --- |
| REAGENT NAME | LINEARITY | SIMPLE PRECISION | COMPLEX PRECISION | COMPARISON TO PREDICATE (COBAS MIRA) |
| CRP | Number [N]:
Linear Range: not applicable.
Limits of Standard Curve:
5 to 129 mg/dL | Number [N]: 20
Normal: CV: 6.3%
Abnormal CV: 1.9% | Number [N]: 80
Normal: CV: 6.7%
Abnormal CV: 2.6% | Number [N]: 100
Slope [m]:
Intercept [b]:
Correlation Coeff: [r]: 0.992 |
| GGT | Number [N]: 8
Linear Range:
0 to 1000 U/L | Number [N]: 20
Normal: CV: 2.9%
Abnormal CV: 1.3% | Number [N]: 80
Normal: CV: 5.9%
Abnormal CV: 2.2% | Number [N]: 100
Slope [m]: 1.07
Intercept [b]: -0.9
Correlation Coeff: [r]: 0.999 |
| Glucose, Hexokinase UV | Number [N]: 5
Linear Range:
0 to 600 mg/dL | Number [N]: 20
Normal: CV: 2.6%
Abnormal CV: 2.3% | Number [N]: 80
Normal: CV: 1.0%
Abnormal CV: 2.9% | Number [N]: 400
Slope [m]: 0.998
Intercept [b]: 7.5
Correlation Coeff: [r]: 0.992 |
| LDH-L | Number [N]: 9
Linear Range:
0 to 1000 U/L | Number [N]: 20
Normal: CV: 2.1%
Abnormal CV: 0.5% | Number [N]: 80
Normal: CV: 2.8%
Abnormal CV: 1.9% | Number [N]: 100
Slope [m]: 1.06
Intercept [b]: 16.2
Correlation Coeff: [r]: 0.992 |
| Phosphorus | Number [N]: 6
Linear Range:
0 to 15.0 mg/dL | Number [N]: 20
Normal: CV: 2.9%
Abnormal CV: 1.2% | Number [N]: 80
Normal: CV: 5.5%
Abnormal CV: 3.1% | Number [N]: 111
Slope [m]: 1.06
Intercept [b]: 0.0
Correlation Coeff: [r]: 0.985 |
| Total Protein | Number [N]: 5
Linear Range:
0 to 12 g/dL | Number [N]: 20
Normal: CV: 1.6%
Abnormal CV: 0.9% | Number [N]: 80
Normal: CV: 2.4%
Abnormal CV: 1.9% | Number [N]: 102
Slope [m]: 1.05
Intercept [b]: -0.09
Correlation Coeff: [r]: 0.983 |
| Triglycerides GPO | Number [N]: 5
Linear Range:
0 to 1000 mg/dL | Number [N]: 20
Normal: CV: 2.8%
Abnormal CV: 1.6% | Number [N]: 80
Normal: CV: 4.2%
Abnormal CV: 3.3% | Number [N]: 102
Slope [m]: 1.025
Intercept [b]: -2.5
Correlation Coeff: [r]: 0.994 |
| Uric Acid | Number [N]: 5
Linear Range:
0 to 20 mg/dL | Number [N]: 20
Normal: CV: 1.7%
Abnormal CV: 1.8% | Number [N]: 80
Normal: CV: 4.2%
Abnormal CV: 4.8% | Number [N]: 100
Slope [m]: 1.02
Intercept [b]: -0.25
Correlation Coeff: [r]: 0.987 |
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HCL Laboratory Systems, Inc.
510(k) Notification for HCL -200
# Claim of Substantial Equivalence to Predicate Device
The safety and effectiveness of the HCL-200 Clinical Chemistry Analyzer is evidenced by:
1. Its equivalent performance to the predicate device, the Roche COBAS MIRA, as summarized in table 5 above and,
2. the fact that the two devices are virtually identical in terms of their use of basic principles of radiant energy measurement, automated liquid handling and data management capabilities.
